Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Immunologic Factors

Participants with stage III node positive cutaneous melanoma will receive subcutaneous PEG-Intron (6.0 ug/kg weekly) for 2 years post-surgery.

Participants with stage III node positive cutaneous melanoma will receive intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for 48 weeks post-surgery.

Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.

PEG-Intron

Interferon alfa-2b, recombinant for intravenous injection.

INTRON A

Medical Director

This is a Phase II/III randomized, controlled, multicenter, open-label study designed to assess the safety, efficacy, and impact on quality of life of PEG Intron (MK-4031) and INTRON® A (MK-2958) and the pharmacokinetics of PEG Intron when given as adjuvant (after surgery) therapy in participants with resected (surgically removed) Stage III node-positive cutaneous melanoma.

This study was closed to enrollment prematurely due to sub-optimal accrual. Participants who were enrolled prior to enrollment closure were allowed to continue to receive study drug; these participants were followed for safety only.

SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)

A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron) vs. INTRON®A as Adjuvant Therapy for Melanoma

Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.

Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.

Merck Sharp & Dohme LLC

Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.

Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery

Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for up to 12 months post-surgery

Total

Age is unknown for 1 participant in each treatment group.

Age, Continuous

Sex: Female, Male

The study was closed to enrollment prematurely due to sub-optimal accrual. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.

Senior Vice President, Global Clinical Development

All randomized participants. Due to the early termination of this study, confirmation of PFS by Independent Central Review was not collected and; therefore, PFS could not be analyzed as planned per protocol.

Progression-free Survival (PFS)

Overall Survival

Overall Study

Lipid Regulating Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Lovastatin

L 647318

Dihydromevinolin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Patients receive outpatient treatment with lovastatin (oral) and interferon alfa-2b (subcutaneous injection) as per protocol parameters.

lovastatin tablets, oral administration, daily dose 1.5 mg/kg, divided into three or four essentially equal doses with meals

lovastatin

interferon alfa-2b for subcutaneous injection, each injection 100,000 international units per kg body mass, three injections weekly

interferon alfa-2b

Stephen B. Cantrell, MD

The purpose of this study is to determine whether an outpatient combination of lovastatin and low-to-moderate dose interferon is effective in the treatment of patients with malignant melanoma.

Malignant melanoma, or simply melanoma, is a potentially fatal cancer which begins as a skin cancer and can spread very aggressively. The incidence of melanoma has been rising rapidly over the last decade and it is now becoming a serious health threat in young adults as well as older adults. Unfortunately, if melanoma escapes complete surgical removal, there are very few treatments which have been found very effective in controlling its growth and spread. If the cancer spreads to the lymph node system or beyond, the chances for long-term survival can be very poor.

This study proposes to test the effectiveness for melanoma treatment of a combination of two medicines which are in widespread use for other medical conditions. Interferon alfa-2b (also known simply as interferon or by a brand name Intron-A) is an exact replica of a protein produced by the human immune system. The human body makes this immune system regulator to help it kill cells in the body which are damaged or infected and thus need to be removed before they can cause further harm to the body. This medicine is often prescribed for infections like hepatitis, some types of cancer including melanoma, and immune system disorders. This study uses interferon in moderate doses, much less than typically used for melanoma treatment when it is used alone, and so the side effects of treatment may be milder. The other medicine being used in combination with it is lovastatin. This medicine is most often used to help patients reduce their cholesterol levels and therefore reduce the risk of heart attacks and strokes. Millions of people use this medicine because it has been found very safe and effective. Research has shown that it also has significant effects against the growth of cancer cells in laboratory cultures and in some animal models.

These two medicines have been used together to treat patients with cancer for several years in our medical practice, but until now they have not been formally tested in a clinical trial. This study will test how well the combination of these medicines can perform and test the hypothesis that they can achieve better survival and control of disease than currently available standard treatment. The incidence of side effects and other details will be monitored too.

This study is open to qualifying patients with stage 2, 3, or 4 melanoma. The results for patients in each group will be compared to other patients in the study with the same or similar stage of disease and with historical results of patients receiving the standard, already-approved treatments for similar stages of melanoma.

Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

Phase 2 Study of Interferon Alfa-2b and Lovastatin Combination Therapy for Patients With High-risk Resected or Unresectable Malignant Melanoma

NeoPlas Innovation

Stephen B. Cantrell MD, Director of Research

Analgesics

Aldesleukin

Interleukin-2

Vemurafenib

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Protein Kinase Inhibitors

Starting dose of Vemurafenib 720 mg by mouth twice daily. Three dose levels of Vemurafenib evaluated in combination with interferon and IL-2. These doses are 480 mg, 720 mg and 960 mg. IL-2 given by continuous venous infusion at starting IL-2 dose of 7 million IU/m2 daily for 4 days (total of 96 hours, days 2-5) starting day 2. IL-2 dose levels are 5MU/m2/day, 7MU/m2/day and 9MU/m2 day. Doses of interferon remain constant at 5 MU/m2 subcutaneously daily for 5 days starting Day 1.

Phase I Starting dose: 720 mg by mouth twice a day for a 21 day cycle.

Phase II Starting dose: Maximum tolerated dose (MTD) from Phase I.

Phase I Starting Dose: 7 million IU/m2 by vein on Days 2 - 5 of a 21 day cycle.

Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I.

IL-2

5 million U/m2 subcutaneously on Days 1 - 5 of a 21 day cycle.

Interferon Alpha-2b

Rodabe N. Amaria, MD

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied.

The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of 6 participants will be enrolled in the Phase I portion of the study and up to 53 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of vemurafenib and aldesleukin you receive will depend on when you joined this study. The first group of participants will receive the lowest dose levels of vemurafenib and aldesleukin. Each new group will receive a higher dose of vemurafenib or aldesleukin than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable doses of vemurafenib and aldesleukin are found.

If you are enrolled in the Phase II portion, you will receive vemurafenib and aldesleukin at the highest doses that were tolerated in the Phase I portion.

All participants will receive the same dose level interferon alfa-2b.

Study Drug Administration:

Each study cycle is 21 days.

You will take vemurafenib by mouth twice a day (1 time in the morning and 1 time in the evening) every day of each study cycle. Vemurafenib can be taken with or without food. If you miss a scheduled dose of vemurafenib, do not try to "make up" the dose by taking 2 doses at the next scheduled dosing time. Continue taking the study drug as scheduled.

You will receive aldesleukin by vein over 96 hours on Days 1-4 of each study cycle.

To receive aldesleukin, you will have a central venous catheter (CVC) inserted, if you do not already have one. A CVC is a sterile flexible tube that will be place into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.

You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each study cycle.

Supportive Drugs:

You will be given other drugs to help lower the risk of side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Study Visits:

The following tests and procedures will be performed:

On Day 1 (+/- 3 days) of each cycle:

* Your performance status will be recorded.
* Your vital signs will be measured.
* You will be asked about any drugs you may be taking and any side effects you may have had.
* If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
* You will have an EKG.

Your skin will be checked for non-melanoma skin cancers on Day 1 of Cycle 1 (+/- 3 days) and then every 3 cycles.

Blood (about 1 teaspoon) will be drawn for routine tests on Days 1, 8, and 15 of each cycle. On Day 1 of each cycle, some of this blood will be used to check your liver and kidney function.

At the end of each cycle (Day 21), you will have a physical exam, including measurement of your weight. Any tumor that can be felt with the hands will be measured with measuring tape during the physical exam to see if it has changed size.

On Day 21 (+/- 7 days) of every 2 cycles, you will have a chest x-ray and a CT or MRI scan to check the status of the disease.

Anytime the doctor thinks it is needed, photos of any skin lesions you have will be taken. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face.

Length of Study:

You may take the study drug combination for as long as the doctor thinks you are benefitting. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.

End-of-Treatment Visit

Within 14 days after you stop taking the study drug combination, the following tests and procedures will be performed:

* Your performance status will be recorded.
* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about any drugs you may be taking and any side effects you may have had.

vBlood (about 2 tablespoons) will be drawn for routine tests.

° If the doctor thinks it is needed, you will have a CT or MRI scan.

Follow-Up Every 3 months for up to 3 years, you will be contacted by phone or during a clinic visit to see how you are doing. The phone call should last about 5 minutes.

This is an investigational study. Vemurafenib, interferon alfa-2b, and Aldesleukin are FDA approved and commercially available to treat metastatic cancer. Giving these drugs in combination is investigational. The study doctor will tell you how the study drugs are designed to work.

Up to 71 patients will take part in this study. All will be enrolled at MD Anderson.

Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor

Systemic Therapy of Metastatic Melanoma With Multidrug Regimen Including Interferon, Interleukin-2 and BRAF Inhibitor

Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any grade 3 or 4 non-hematological toxicity excluding manageable N/V, diarrhea and fatigue and manageable/replaceable grade 3 or 4 electrolyte abnormalities, and appearance of new squamous cell skin cancers. Toxicity that may result in delaying next course for more than 3 weeks. Any grade 4 neutropenia more than 7 days duration or Grade 4 thrombocytopenia lasting more than 7 days.

Progression-free survival estimated using the method of Kaplan-Meier. It will be determined from the start of the study until disease progression or death, whichever is first.

M.D. Anderson Cancer Center

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Ipilimumab starting dose 2 mg/kg intravenous (IV) day 1 only; IFN alfa-2b at 5 million U/m2 subcutaneously daily for 5 days starting day 1; IL-2 at 9 million IU/m\^2 daily IV continuous infusion for 4 days on days 2-5.

Starting dose 2 mg/kg by vein on day 1 of each of the four 3-week cycles (Phase II is maximum tolerated dose (MTD) from Phase I). During Consolidation and Maintenance phases one dose every 12 weeks.

5 million U/m2 subcutaneously daily for 5 days starting day 1 of each Induction and Consolidation cycle.

Interferon

9 million IU/m\^2 daily by vein by continuous infusion for 4 days (total of 96 hours, days 2-5) starting day 2 of each Induction and Consolidation cycle.

Interleukin-2 (Aldesleukin)

Agop Y. Bedikian, MD,BS

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A (interferon alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma.

Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 5 groups of 3-6 participants will be enrolled in the Phase I portion of the study, and up to 64 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of ipilimumab you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of ipilimumab. Each new group will receive a higher dose of ipilimumab than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ipilimumab is found.

If you are enrolled in the Phase II portion, you will receive ipilimumab at the highest dose that was tolerated in the Phase I portion.

All participants will receive the same dose level of interferon alfa-2b and aldesleukin.

Study Drug Administration:

The study drugs will be given in 3 stages: induction, consolidation, and maintenance.

Induction:

Induction will last 12 weeks. You will receive the study drugs in up to four 3-week cycles:

* You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle.
* You will receive aldesleukin in the hospital by vein as a continuous infusion on Days 2-5 of each cycle.
* You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each cycle.

Consolidation:

Consolidation will last 12 weeks. You will receive the study drugs in up to four 3-week cycles:

* You will receive ipilimumab by vein over 90 minutes on Day 1 of Cycle 1.
* You will receive aldesleukin in the hospital by vein as a continuous infusion on Days 2-5 of each cycle.
* You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each cycle.

Maintenance:

Maintenance will last about 1½ years. You will receive ipilimumab by vein over 90 minutes on Day 1 of up to six 12-week cycles.

Other Drugs:

You will be given other drugs to help lower the risk of side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Study Visits:

Before each cycle (+/- 3 days):

* You will be asked about any drugs you may be taking and any side effects you may have had.
* Your performance status will be recorded.
* Your vital signs will be measured.
* Blood (about 1 teaspoon) will be drawn for routine tests and tests of your liver and kidney function.
* If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Every week, blood (about 1 teaspoon) will be drawn for routine tests.

At the end of each cycle, you will have a physical exam, including measurement of your weight. Any tumor that can be felt with the hands will be measured during the physical exam to see if it has changed size.

Every 2 cycles (+/- 7 days), you will have a chest x-ray and CT or MRI scans to check the status of the disease.

Anytime the doctor thinks it is needed, photos of the skin lesions will be taken. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face.

Length of Study:

You may continue taking the study drugs for up to 2 years. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.

End-of-Treatment Visit:

Within 14 days after you stop the study therapy, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and any side effects you may have had.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have a CT or MRI scan.

Every 2 months for up to 3 years, you will also be contacted by phone or during a clinic visit to see how you are doing.

This is an investigational study. Ipilimumab, interferon alfa-2b, and aldesleukin are FDA approved and commercially available to treat melanoma. Giving these drugs in combination is investigational.

Up to 88 patients will take part in this study. All will be enrolled at MD Anderson.

IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma

IPI-Biotherapy for Patients With Metastatic Melanoma Previously Treated With Cytotoxic Drugs

Progression-free survival determined from the start of the study until disease progression or death, whichever is first and estimated using the method of Kaplan-Meier.

Paclitaxel

Temozolomide

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Abraxane with Cisplatin, Temozolomide, interleukin-2 and interferon a2b

250 mg/m\^2 by mouth on days 1, 2, and 3 of each 21-day cycle.

100 mg/m\^2 given in a short intravenous infusion 1 hour after completion of Temozolomide and a 2nd dose of 70 mg/m\^2 given on day 5 of each 21-day cycle.

Abraxane

20 mg/m\^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle.

9 MIU/m\^2 in a continuous intravenous infusion over 24 hours on days 1, 2, 3, and 4 (total of 96 hours) beginning after completion of Cisplatin of each 21-day cycle.

5 MIU/m\^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle.

Interferon alpha 2b

Nicholas E. Papadopoulos, MD

The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.

Primary Objective:

* The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.

Secondary Objectives:

* To assess responses to the combination.
* To evaluate the duration of response and the overall survival.
* To determine the effectiveness in delaying the appearance of Central Nervous System disease.

The Study Drugs:

Cisplatin, nab-paclitaxel, and temozolomide are chemotherapy drugs and have a direct effect on melanoma cells. Interferon alfa-2b and IL-2 are biotherapy drugs that stimulate the immune system to fight against melanoma. The combination of chemotherapy and biotherapy drugs is called biochemotherapy.

This is the first study using these drugs in combination.

Catheter:

If you are found to be eligible to take part in this study, you will have a central venous catheter (CVC) inserted, if you do not already have one. The catheter is passed through the veins of your arm or the veins that run under your collar bone to reach a wide central vein in the chest that runs above your heart. You will receive a separate consent form for this procedure, which describes the risks.

Nab-paclitaxel, cisplatin, and interleukin-2 are given through this catheter. In certain situations, blood can also be drawn from this catheter.

Study Drug Dose Levels:

You will be assigned to a dose level of nab-paclitaxel based on when you joined this study. Up to 3 dose levels of nab-paclitaxel will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of nab-paclitaxel that can be given in combination with the other drugs is found.

All participants will receive the same dose level of temozolomide, cisplatin, interferon alfa-2b, and IL-2.

Study Drug Administration:

Each study cycle will last 3-5 weeks. The length of each cycle will depend on your recovery from the study drugs.

On Day 1 of each cycle:

* You will take temozolomide by mouth.
* You will receive nab-paclitaxel over about 30 minutes by vein about 1 hour after you take temozolomide.
* You will then receive cisplatin by vein. Each infusion of cisplatin will take about 45-120 minutes.
* You will receive interferon alfa-2b by injection into fatty tissue.
* You will begin your IL-2 infusion. The infusion will begin after you receive cisplatin and will continue non-stop until Day 5.

On Day 2 of each cycle:

* You will take temozolomide by mouth.
* You will receive cisplatin by vein about 1 hour after you take temozolomide.
* You will receive interferon alfa-2b by injection into fatty tissue.

On Day 3 of each cycle:

* You will take temozolomide by mouth.
* You will receive cisplatin by vein about 1 hour after you take temozolomide.
* You will receive interferon alfa-2b by injection into fatty tissue.
* Blood (up to 4 teaspoons total) will be drawn for routine tests and tests to check for infection in the blood.

On Day 4 of each cycle:

* You will receive cisplatin by vein.
* You will receive interferon alfa-2b by injection into fatty tissue.
* Blood (up to 4 teaspoons) will be drawn for routine tests.

On Day 5 of each cycle:

* You will receive nab-paclitaxel by vein over about 30 minutes.
* You will receive interferon alfa-2b by injection into fatty tissue.
* Blood (up to 4 teaspoons) will be drawn for routine tests.

Depending on how your body reacts to the study drugs, you will stay in the hospital for 7 or more days.

After you are discharged from the hospital, blood (up to 4 teaspoons) will be drawn 2 times a week for routine tests.

Study Visits:

Before starting each cycle of treatment:

* Your medical history will be recorded.
* You will have a physical exam.
* Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your blood counts.
* You will have a chest x-ray.

After every 2 cycles of treatment, you will have CT scans and an MRI scan of the brain to check the status of the disease. If you have disease in the bone, you will have a PET/CT to check the status of the disease.

If you have skin lesions, you will have them photographed to check the status of the disease.

Length of Study:

You may receive up to 6 cycles of the study drugs. You will be taken off study early if the disease gets worse or intolerable side effects occur.

Follow-Up Contact:

If you are having follow-up visits with a doctor who is not at M. D. Anderson, you will be called 2-4 times a year to learn what treatments you may be receiving and how are you doing. You will continue to receive these calls for as long as possible. The phone calls will take about 5 minutes.

This is an investigational study. Nab-paclitaxel is FDA approved and commercially available for breast cancer. Temozolomide is FDA approved and commercially available for brain cancer. Cisplatin is FDA approved and commercially available for testicular, ovarian, and bladder cancers. Interferon is FDA approved and commercially available for patients with melanoma who are having surgery. IL-2 is FDA approved and commercially available for melanoma and kidney cancer. The combination of these drugs is investigational.

Up to 24 patients will be take part in this study. All will be enrolled at M. D. Anderson.

Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma

Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antimony Sodium Gluconate

Antiprotozoal Agents

Antiparasitic Agents

Anthelmintics

Sodium Stibogluconate (SSG) 400 mg/m\^2 intravenous (IV) daily on days 1-5 + Interferon Alfa-2b (Intron A) 3x10\^6 units subcutaneously three times weekly

Sodium Stibogluconate

3x10\^6 units subcutaneously three times weekly

Aung Naing, MD

Primary Objective:

-To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies.

Secondary Objectives:

* To correlate the AUC of SSG with clinical toxicity and efficacy.
* To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal transduction pathways.
* To characterize the effects of SSG on PTPases SHP-1 and SHP-2.
* To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.

Sodium stibogluconate is a drug that is able to block an enzyme in the cells that is responsible for cell growth. By blocking this enzyme, it may be able to prevent cancer cells from multiplying.

Interferon alfa-2b is a drug that activates an immune response to infections in the body. By triggering an immune response, this drug may help to prevent some cancer cells from growing and multiplying. You will receive treatment with both sodium stibogluconate and interferon alfa-2b, because sodium stibogluconate may improve the effectiveness of interferon in treating the cancer.

Participants will be enrolled in groups of 3 on this study, and the doses of the study drugs will be escalated for each group. This means that each new group of 3 participants will get a higher dose of the study drugs than the group before them. This will continue until the highest tolerable dose combination is found.

Once the highest tolerable dose has been found, up to an additional 9 participants, called the expansion group, will receive study drug at that dose. Your doctor will tell you if you are in the expansion group.

If you are found to be eligible to take part in this study, you will go to the clinic to start treatment. During Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5. On Days 8-12, you will be given sodium stibogluconate once a day by vein, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 8, 10, and 12. For every cycle after Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5 and 8-12, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 1, 3,5, 8, 10, and 12. Treatment cycles will last about 3 weeks (2 weeks on treatment, followed by 1 week off treatment).

During each visit to the clinic, you will be asked how you are feeling, and your vital signs will be measured. You will have a complete physical exam the first day of every cycle. On Days 1, 8, and 12 of every cycle, you will have a urine test to check the function of your kidneys, and blood (about 3 teaspoons) will be drawn for routine tests. On Days 1, 8, and 12 of every cycle and during your last study visit, you will have an additional blood draw (about 5 teaspoons) for immunological testing (to help researchers learn how your body fights disease) before treatment. On Days 1, 5, 8, and 12 of every cycle, you will have an ECG after you receive treatment.

At some time during the week before Day 1 of Cycle 1 and on Day 12 of Cycle 2, you may have a tumor biopsy to check the status of the disease before you receive the study drug. To perform a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tumor tissue is withdrawn through a large needle. Your doctor will tell you if this may be necessary.

On Days 1, 2, 9, 12, and 13 of Cycle 1, you will have blood drawn (about 1 teaspoon each) for PK testing. On Days 1, 8, and 12, the PK testing will be done before, 30 minutes after, and 2 hours after you receive the study drug. On Days 2 and 9, the PK testing will be done before treatment. On Day 13, the PK testing will be done 24 hours after you received treatment on Day 12.

After Cycle 1, you will be scheduled to return to the clinic in 10 days to receive treatment for Cycle 2, which will follow in the same manner as Cycle 1.

At the end of Cycle 2 and every even-numbered cycle (Cycles 4, 6, 8, and so on) after that, you will have imaging studies, such as x-rays and CT scans, to check the status of your tumors.

If the disease does not get worse and you do not experience any intolerable side effects after Cycle 1, you will continue on to Cycle 2, and so on. If at any time the disease gets worse or you experience any intolerable side effects, you will be taken off this study.

This is an investigational study. Sodium stibogluconate is not FDA approved or commercially available. It is authorized for use in research only. Interferon alfa-2b is approved by the FDA for the treatment of some types of cancers (solid tumors). The combination of these drugs is investigational in this study. Their use together is authorized for use in research only.

However, if sodium stibogluconate becomes commercially available while you are still on study. Up to 54 patients will take part in this multicenter study. Up to 35 will be enrolled at M. D. Anderson.

Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sodium Stibogluconate in Combination With Interferon Alpha-2b for Patients With Advanced Malignancies

MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs.

VioQuest Pharmaceuticals

Ipilimumab starting 1 mg/kg by vein (IV) Day 1 each cycle; Temozolomide 200 mg/m\^2 orally Days 2-5 of Induction; Cisplatin 25 mg/m\^2 IV for Days 2-4 of Induction; Interferon alfa-2b 5 million U/m2 subcutaneously on Days 1-5 of each cycle Induction + Consolidation; and Interleukin-2 9 million IU/m\^2 IV as a continuous infusion on Days 2-5 of Induction + Consolidation.

Phase I Starting dose: 1 mg/kg by vein over 90 minutes on Day 1 of each 3 week cycle for Induction 12 weeks, then Day 1 of Cycle 1 for Consolidation 12 weeks and Day 1 of each 12 week cycle in Maintenance.

Phase II dose: Maximum tolerated dose (MTD) from Phase I.

200 mg/m\^2 by mouth 1 time a day on Days 2-5 of each Induction cycle (four 3 week cycles).

25 mg/m\^2 by vein over 1 hour on Days 2-4 of each Induction cycle (four 3 week cycles).

5 million U/m2 subcutaneously on Days 2-6 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).

Interferon Alfa-2b

9 million IU/m\^2 by vein as a continuous infusion on Days 2-5 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma. Note: The study was closed following Phase I enrollment.

Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer.

Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.

Cisplatin is designed to poison the cancer cells, which may cause them to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 6 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 46 participants will be enrolled in Phase II.

\*\*\*Study was halted early due to slow accrual in the Phase I portion without opening Phase II. \*\*\*

If you are enrolled in the Phase I portion, the dose of ipilimumab you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of ipilimumab. Each new group will receive a higher dose of ipilimumab than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ipilimumab is found.

If you are enrolled in the Phase II portion, you will receive ipilimumab at the highest dose that was tolerated in the Phase I portion.

All participants will receive the same dose level of cisplatin, temozolomide, interferon alfa-2b and IL-2.

If you develop intolerable side effects while on study, your dose of IL-2 may be lowered 1-2 times until the side effects get better.

Catheter:

If you are found to be eligible to take part in this study, you will have a central venous catheter (CVC) inserted, if you do not already have one. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.

Study Drug Administration:

The study drugs will be given in 3 stages: induction, consolidation, and maintenance.

Induction:

Induction will last 12 weeks. You will receive the study drugs in up to four 3-week cycles:

* You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle.
* You will take temozolomide by mouth 1 time a day on Days 2-5 of each cycle. You should take temozolomide on an empty stomach at least 2 hours before or after a meal. Do not open the capsule, mix it with food, or chew it.
* You will receive cisplatin by vein over 1 hour on Days 2-4 of each cycle.
* You will receive aldesleukin by vein as a continuous infusion on Days 2-5 of each cycle.
* You will receive interferon alfa-2b as an injection under your skin on Days 2-6 of each cycle.

Consolidation:

Consolidation will last 12 weeks. You will receive the study drugs in three 4-week cycles.

* You will receive ipilimumab by vein over 90 minutes on Day 1 of consolidation.
* You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each cycle.
* You will receive aldesleukin by vein as a continuous infusion on Days 2-5 of each cycle.

Maintenance:

Maintenance will last about 1½ years. You will receive ipilimumab by vein over 90 minutes on Day 1 of up to six 12-week cycles.

Other Drugs:

You will be given other drugs to help decrease the risk of side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Study Visits:

Before each cycle (+/- 3 days):

* You will be asked about any drugs you may be taking and any side effects you may have had.
* Your performance status will be recorded.
* Your vital signs will be measured.
* If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Every week, blood (about 1 teaspoon) will be drawn for routine tests. Before each cycle, some of this blood will be used to check your liver and kidney function.

At the end of each cycle, you will have a physical exam, including measurement of your weight. Any tumor that can be felt with the hands will be measured during the physical exam to see if it has changed size.

Every 2 cycles (+/- 7 days), you will have a chest x-ray and CT or MRI scans to check the status of the disease.

Anytime the doctor thinks it is needed, photos of the skin lesions will be taken. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face.

Length of Study:

You may continue taking the study drugs for up to 2 years. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.

End-of-Treatment Visit:

Within 14 days after you stop the study therapy, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and any side effects you may have had.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have a CT or MRI scan.

Follow-Up:

Every 2 months for up to 3 years, you will be contacted by phone or during a clinic visit to see how you are doing.

This is an investigational study. Temozolomide, cisplatin, ipilimumab, interferon alfa-2b, and aldesleukin are FDA approved and commercially available to treat metastatic cancer. However, it is investigational to give temozolomide to patients with metastatic melanoma.

Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.

IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma

IPI-Biochemotherapy for Chemonaive Patients With Metastatic Melanoma

Tumor assessments using irRC modified World Health Organizations (WHO) criteria: Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions. Immune-Related Partial Response (irPR): decrease of 50% or greater. Immune-Related Progressive Disease (irPD): At least 25% increase in sum of products of all index lesions over baseline sum of products of diameters (SPD) calculated for index lesions. Assessment include photographic measurement of skin lesions, computed tomography scans and/or magnetic resonance imaging tumor assessments until documented tumor progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)	NCT03552549	Melanoma	PEG-Intron INTRON A	18 Years - 70 Years	Merck Sharp & Dohme LLC
Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma	NCT00963664	Melanoma Malignant Melan...	lovastatin interferon alfa...	18 Years -	NeoPlas Innovation
Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor	NCT01603212	Melanoma	Vemurafenib IL-2 Interferon Alph...	18 Years - 65 Years	M.D. Anderson Cancer Center
IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma	NCT01409187	Melanoma	Ipilimumab Interferon Interleukin-2 (...	18 Years - 65 Years	M.D. Anderson Cancer Center
Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma	NCT00970996	Melanoma	Temozolomide Abraxane Cisplatin Interleukin-2 Interferon alph...	18 Years - 65 Years	M.D. Anderson Cancer Center
IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma	NCT01409187	Melanoma	Ipilimumab Interferon Interleukin-2 (...	18 Years - 65 Years	M.D. Anderson Cancer Center
Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies	NCT00629200	Advanced Cancer Solid Tumors	Sodium Stiboglu... Interferon Alph...	18 Years -	M.D. Anderson Cancer Center
SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)	NCT03552549	Melanoma	PEG-Intron INTRON A	18 Years - 70 Years	Merck Sharp & Dohme LLC
Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma	NCT00970996	Melanoma	Temozolomide Abraxane Cisplatin Interleukin-2 Interferon alph...	18 Years - 65 Years	M.D. Anderson Cancer Center
IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma	NCT01409174	Melanoma	Ipilimumab Temozolomide Cisplatin Interferon Alfa... Interleukin-2	18 Years - 65 Years	M.D. Anderson Cancer Center
Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma	NCT00963664	Melanoma Malignant Melan...	lovastatin interferon alfa...	18 Years -	NeoPlas Innovation

Spots Global Cancer Trial Database for intron a

Every month we try and update this database with for intron a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for intron a

Every month we try and update this database with for intron a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for intron a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.