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

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Azacitidine

Decitabine

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Immunologic Factors

Antimetabolites

Enzyme Inhibitors

Decitabine starting dose of 10mg/m\^2 given daily via intravenous infusion on days 1-5 of 28 day cycle. Peginterferon Alfa-2b starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.

Starting dose of 10mg/m\^2 given daily via intravenous infusion on days 1-5 of 28 day cycle.

Starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.

Pegylated Interferon Alpha-2b

Wen-Jen Hwu, MD, PhD

The goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied.

The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are more effective and/or better tolerated.

The Study Drugs:

Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.

Peginterferon alfa-2b is designed to strengthen the immune system, which may decrease tumor growth.

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 joined this study. Up to 6 groups of 3-6 participants will be enrolled in the Phase I portion of the study, and up to 44 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of decitabine and peginterferon alfa-2b you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drug combination. Each new group will receive a higher dose level than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.

If you are enrolled in the Phase II portion, the dose of decitabine and peginterferon alfa-2b you receive will depend on when you joined this study, as well as the research data from the Phase I portion. You will be randomly assigned (as in the roll of dice) to receive one of the dose levels (which may be from 1 to 6 dose levels, depending on the available data from the Phase I portion) that have been found in the Phase I portion to have the least side effects and to be possibly the most effective. This means you will have an equal chance of being assigned to any of the dose levels that are being used at that time. As the study goes on, if the research data suggests that one dose level may be better tolerated than the others, new participants enrolling into the Phase II portion would be more likely to be assigned to that possibly better dose level.

No matter which phase you are enrolled in, your dose of the study drugs may be lowered if you do not tolerate the study drug combination well.

Study Drug Administration:

A "cycle" on this study is 28 days. Decitabine will be given by vein, over 1 hour, on Days 1-5 of each cycle. Peginterferon alfa-2b will be given by injection under the skin, once a week (on Days 1, 8, 15, and 21). You will be giving peginterferon alfa-2b to yourself under nursing supervision on the days you are receiving decitabine.

On Day 6 of each cycle, you will either receive Neulasta (pegfilgrastim) or Neupogen (filgrastim). Pegfilgrastim or filgrastim will be injected under your skin. If you receive pegfilgrastim, it will be injected only on Day 6 of each cycle. If you receive filgrastim, it will be injected 1 time a day for as many days as the doctor decides is needed to raise your white blood cell count.

Study Visits:

On Day 1 of each cycle, the following procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about any medications or treatments you may be currently receiving and any side effects you may have experienced.
* You will have a performance status evaluation.
* Blood (about 1 teaspoon) will be drawn for routine tests.

These same tests listed above will be repeated at additional visits with the research nurse during Week 3 of Cycles 1 and 2. If you do not experience severe side effects during Cycles 1 and 2, these extra Week 3 visits with the research nurse will no longer be necessary in later cycles. They may, however, be started again if needed.

At the end of of Cycle 3, and every odd cycle after that (Cycles 5, 7, 9, and so on), you will have a scan performed (such as CT or MRI) to check the status of the disease.

Length of Study Participation:

You may remain on study for as long as you are benefitting. If the disease gets worse or intolerable side effects occur, you will be taken off study early.

End-of-Study Visit:

Once you go off study for any reason, you will have an end-of-study visit with the same procedures performed as the Day 1 study visits. You may also have a scan performed (such as CT or MRI) to check the status of the disease if you have not had one performed in the last 4 weeks.

Long-Term Follow-Up:

Every 3 months for about 2 years, researchers will call you to see how you are doing.

This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Peginterferon alfa-2b is FDA approved and commercially available for the treatment of hepatitis C. Their use together in this study in the treatment of melanoma is considered experimental. At this time, the combination is being used in research only.

Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.

Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma: Phase I Portion

A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Peginterferon Alfa-2b in Advanced Melanoma

Dose limiting toxicity defined as any treatment related toxicity that meets one or more of the following criteria:

Any grade 3 or 4 non-hematologic toxicity regardless of duration, except:

1. Grade 3 nausea or vomiting occurring without maximal antiemetic therapy.
2. Grade 3 diarrhea that occurs following without adequate loperamide therapy.

   * Grade 4 thrombocytopenia.
   * Grade 4 neutropenia lasting \> 2 weeks or associated with infection.
   * Any toxicity that results in a treatment delay of \> 4weeks.

Success defined as either a complete response (CR), a partial response (PR), or stable disease (SD). Target combined endpoint of CR+PR+SD in this trial is 30%. Evaluation of response follows the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines.

Schering-Plough

Eisai Inc.

M.D. Anderson Cancer Center

Vaccines

Pegylated Interferon alfa-2b (Once week x 4 weeks) + GP-100 Peptide

Pegylated Interferon alfa-2b (Once week x 8 weeks) + GP-100 Peptide

Pegylated Interferon alfa-2b (Once week x 12 weeks) + GP-100 Peptide

Group 1:

6 mcg/kg by injection under skin once weekly for 4 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 20 weeks.

Group 2:

6 mcg/kg by injection under skin once weekly for 8 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 16 weeks.

Group 3:

6 mcg/kg by injection under skin once weekly for 12 weeks followed by Maintenance Phase of 3 mcg/kg weekly for 12 weeks.

Pegylated Interferon-Alfa 2b (PEG Intron)

Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.

GP-100 Peptide Vaccine

The goal of this clinical research study is to find the best dosing schedule of a combined treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that may help improve immune response in patients that had Stage II or Stage III melanoma and are free of the disease. The safety and tolerability of this drug combination will also be studied. Researchers also want to collect long-term follow-up information.

The Study Drugs:

Pegylated Interferon alfa-2b is a protein made by the human immune system that helps to fight viral infections and regulate cell function.

Gp100 is a protein that is found on melanoma cells. In laboratory studies, the gp100 vaccine has been shown to stimulate the immune system to "recognize" and kill melanoma cells that have gp100 on their cell surfaces.

Evaluation of Immune cell response to vaccine:

Blood (about 3-1/2 tablespoons) will be drawn on Weeks 4, 7,10,13,16,19, and 22 for tests to check the response of your immune system to the vaccine, before each injection. These tests are for research purposes only and will not be used to make decisions about your medical care.

Parts of the Study:

There are 2 parts to this study, an Induction Phase and a Maintenance Phase. The Induction Phase treatment is the first course of treatment used to stimulate ("turn on") an immune-cell response to fight cancer and to learn the body's response to the treatment. The Maintenance Phase treatment is continued therapy and is used to maintain the immune-cell response and to help keep the disease in remission.

Study Groups:

If participant is found to be eligible to take part in this study, they will be randomly assigned (as in the roll of dice) to 1 of 3 treatment groups. Participant will have an equal chance of being assigned to one of each of the groups. Participants in each group will receive the same dose levels of pegylated Interferon alfa-2b and gp100. The difference between each group will be the dosing schedule of pegylated Interferon alfa-2b.

Every week, participant will give themselves the pegylated Interferon alfa-2b either in the clinic or at home, and the gp100 will be given to participant every 3 weeks by the research nurse in the clinic. Participant will be shown how to give yourself Pegylated Interferon alfa-2b at home.

Pegylated Interferon alfa-2b will be given immediately after the GP-100 Peptide Vaccine injection.

Participants in Group 1 will take pegylated Interferon alfa-2b at a certain dose level once a week for 4 weeks (in the Induction Phase), followed by once a week for 20 weeks in the Maintenance Phase (when the drug will be taken at a lower dose level than during Induction).

Participants in Group 2 will take pegylated Interferon alfa-2b at a certain dose level once a week for 8 weeks (in the Induction Phase), followed by once a week for 16 weeks in the Maintenance Phase (when the drug will be taken at a lower dose level than during Induction).

Participants in Group 3 will take pegylated Interferon alfa-2b at a certain dose level once a week for 12 weeks (in the Induction Phase), followed by once a week for 12 weeks in the Maintenance Phase (when the drug will be taken at a lower dose level than during Induction).

Study Treatment:

Participant will take pegylated Interferon alfa-2b as an injection just under their skin. Participant will receive gp100 as an injection just under their skin once every 3 weeks.

On Week 1, PEG-Intron will be given right after GP-100 Peptide Vaccine injection in the clinic. Participant will be observed for at least 30 minutes after both GP-100 Peptide Vaccine and PEG-Intron Injections.

On Weeks 4, 7, 10, 13, 16, 19, and 22 (+/- 1 day, not counting institutional holidays), GP-100 peptide will be given in the clinic. Participant will be observed for at least 30 minutes after GP-100 Peptide Vaccine injection. Participant should give the PEG-Intron to themselves within 24 hours of GP-100 Peptide Vaccine injection. The injection of gp100 will be given in two separate areas of participant's limbs, such as in an upper arm or thigh. It will be given in the same area each time.

Length of Study:

Participant will remain on this study for up to 25 weeks, unless the disease comes out of remission or they experience intolerable side effects.

End-of-Treatment Visit:

At the end of study treatment (approximately 3 weeks after the last injection of gp100), participant will have the following tests:

* Participant will have a review of their general health and any medical problems they may be having.
* Participant will have a physical exam, including measurement of their vital signs.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* Participant will have the leukapheresis repeated.
* Participant will have a CT scan of chest, stomach, and pelvis, and they will have an MRI or CT scan of the brain.

While participant is on this study no steroids will be allowed while on treatment.

This is an investigational study. Pegylated Interferon alfa-2b is FDA approved and commercially available for the treatment of chronic hepatitis C. Gp100 is not FDA approved or commercially available. At this time, the combination use of pegylated Interferon alfa-2b plus gp100 is being used for research purposes only in this study.

Up to 30 participants will take part in this study. All will be enrolled at MD Anderson.

Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine

An Exploratory Study of Adjuvant Therapy of Pegylated Interferon-Alfa 2b Plus Melanoma Peptide Vaccine in Patients With Resected Stage II and III (N1a, N2a) Melanoma

Merck Sharp & Dohme LLC

Blood and Lymph Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Cytarabine

Immunosuppressive Agents

Peg Interferon Alpha 2b (Peg Intron) 4.5 micrograms/kg once a week. ARA-C 10 mg under the skin daily.

Peg Interferon Alpha 2b (Peg Intron)

Ara-C (cytosine arabinoside)

Jorge E Cortes, MD

The goal of this clinical research study is to see if a new interferon which is given only once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of this treatment will also be studied.

If you agree to take part in this study, during treatment, you will have blood tests every 1 to 4 weeks. After 10 years, blood tests are recommended 2 times per year. Bone marrow samples will be taken every 3 months during the first year and then every 3 to 6 months. If you are on this study for 10 years or longer, the bone marrow collections will only be performed if the doctor thinks it is needed. To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

During treatment, you will receive PEG-Intron once a week. You will also receive Ara-C injections under the skin. You will be taught to inject yourself, or a family member or friend can be taught how to give injections. Treatment will be given to you in the outpatient clinic at MD Anderson or in a clinic close to you.

You will receive treatment as long as it is helping to control the disease. Treatment will go on for about 5 to 20 years.

This is an investigational study. The FDA has approved PEG-Intron only for research studies. About 100 patients will take part in this study. All will be enrolled at MD Anderson.

PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML

Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)

Cytogenetic responses evaluated by routine cytogenetics.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma: Phase I Portion	NCT00791271	Melanoma	Decitabine Pegylated Inter...	18 Years -	M.D. Anderson Cancer Center
Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine	NCT00861406	Melanoma	Pegylated Inter... GP-100 Peptide ...	18 Years -	M.D. Anderson Cancer Center
Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine	NCT00861406	Melanoma	Pegylated Inter... GP-100 Peptide ...	18 Years -	M.D. Anderson Cancer Center
PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML	NCT00303290	Chronic Myeloid...	Peg Interferon ... Ara-C (cytosine...	12 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for peg intron

Every month we try and update this database with for peg intron 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 peg intron

Every month we try and update this database with for peg intron 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 peg intron 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.