Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Ascorbic Acid

Melphalan

Arsenic Trioxide

Trace Elements

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antioxidants

Protective Agents

Vitamin C

Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)

Dose Level 1: None; Dose Level 2: 0.15 mg/kg days Intravenous (IV) Days -9 to -3; Dose Level 3: 0.25 mg/kg days IV Days -9 to -3.

Dose Levels 1, 2, \& 3: 100 mg/m2 IV Days -4, -3.

Dose Levels 1, 2, \& 3: 1000 mg IV Days -9 to -3.

Muzaffar H. Qazilbash, MD

1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics

Treatment:

High-dose melphalan followed by a transplant of autologous stem cells is thought to be one of the most effective ways to treat multiple myeloma. However, the number one cause of treatment failure in these patients is the disease coming back.

High-dose melphalan has been used in multiple myeloma for more than two decades and is considered the standard of care for this disease. Recent research in the laboratory and clinical trials has shown that Arsenic trioxide is an effective treatment against multiple myeloma. It leads to tumor cell death in myeloma cell lines and in myeloma patients. Arsenic trioxide can also make melphalan a more effective antimyeloma agent. This research has also shown that vitamin C enhances the anti-myeloma activity of arsenic trioxide by making it more toxic to myeloma cells. The purpose of this study is to learn if a combination of arsenic trioxide, vitamin C, and melphalan will be safe, well-tolerated and effective in myeloma patients.

Before treatment begins, you will have several tests performed to study the status of the disease before you begin taking the study medication. You will have a bone marrow aspirate and biopsies. An aspirate is the drawing of liquid marrow with a syringe, while a biopsy is the removal of a small core of bone with a hollow needle. Aspirate can be done from the hip bone or chest, while biopsy is always from the hip bone. You will have cytogenic tests, to see if there are any genetic abnormalities in your DNA. You will have a bone survey done, where the doctor will look at X-rays of your bones for any myeloma-related bone changes.

You will have routine and specialized blood tests done (about 2 tablespoons), to measure blood counts, platelets, blood clotting, kidney function, electrolyte counts, and levels of disease in your blood. You will also have a urine test to measure level of myeloma in your urine. You will have a pulmonary function test, to check if your lungs is strong enough to withstand high-dose chemotherapy. You will have an initial electrocardiogram (EKG) and also a MUGA scan that will measure how strong your heart functions are.

Women who are able to have children must have a negative blood pregnancy test before participating in this study.

If you agree and are eligible, you will be assigned to receive one of 3 arms. In the first arm only melphalan and vitamin C, but no Arsenic trioxide will be given. In the second and third arms, doses of arsenic trioxide together with Vitamin C and melphalan will be given. Not all patients in this study will get the same dose of arsenic. Your dose assignment will depend on the experience of other patients with this combination. The first 3 patients on this study will get the lowest dose of arsenic trioxide.

Arsenic trioxide will be given through a needle in the vein over a period of 2 hours, once a day for 7 days. At the same time, vitamin C will be given once a day through the vein for 7 days. On the last 2 days of arsenic trioxide treatment, melphalan will be given through the vein over one hour after the arsenic. You will have your stem cells reinfused 2 days after the last dose of melphalan.

Some patients agreeing to the optional procedure will receive one of the doses of melphalan before starting the arsenic.

You will receive standard inpatient and outpatient transplant care and testing. This involves blood and bone marrow tests, heart tests, lung tests and x-rays before the study drug treatment and the transplant. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Blood tests (about two tablespoons) will be drawn at least once a week for the first month after the transplant, and then once every month for the next 3 months.

Bone marrow biopsies and tests to check the level of myeloma protein in the urine and the blood are also performed at 3, 6 and 12 months after the transplant.

You will be taken off study one year after transplant, if your disease does not come back. Patients off study will still return for their routine post-transplant follow up visits as decided by their transplant physician. If your disease comes back or intolerable side effects occur, you will be taken off study.

This is an investigational study. Both arsenic trioxide and melphalan are commercially available and have been approved for use in patients with myeloma, though their use together with vitamin C is investigational. About 32 patients are expected to participate in this study. All will be enrolled at UTMDACC.

Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

Phase I/II Study of the Combination of Arsenic Trioxide With Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma

Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.

CTI BioPharma

M.D. Anderson Cancer Center

Arsenic Trioxide + Vitamin C + Melphalan

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Muzaffar H. Qazilbash, MD / Associate Professor

Complete Response

Overall Response (Complete + Partial Response)

Response Rate

Overall Study

Leukemia

Leukemia, Promyelocytic, Acute

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute Graft Versus Host Disease

Acute Promyelocytic Leukemia

Dermatologic Agents

Tretinoin

Daily oral NRX 195183 administration for 90 days to assess CR rate. Patients with CR may continue maintenance therapy after a 2-week drug holiday. Maintenance therapy will consist of two 3-month daily oral NRX 195183 administration separated by a 2-week drug holiday.

NRX 195183 Soft Gelatin Capsule

Nonna Snider, BS/BA

Linda Gero

Victoria Chua

The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia

A common current therapeutic approach to APL uses oral ATRA and chemotherapy in induction and consolidation. This approach has significantly improved survival in newly diagnosed APL patients. However, approximately 30% of patients relapse. Recently, an approach involving the combination of oral ATRA and arsenic trioxide has been tested. The prognosis for relapsed patients is very poor. This study seeks to investigate NRX 195183 monotherapy in patients who have failed or are resistant to or are intolerant of any prior therapy.

Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

NuRx Pharmaceuticals, Inc.

Roshantha A. Chandraratna, PhD, MBA, Chief Scientific Officer

Keratolytic Agents

This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.

Tretinoin and Arsenic Trioxide

Jae Park, MD

The purpose of this study is to find what effects, good and/or bad, treatment with two drugs has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA, or Vesanoid). It is an approved medicine that causes the leukemia cells in APL to mature. It is related to vitamin A. The second is arsenic trioxide (Trisenox). It is an approved medicine for APL that comes back after earlier treatment.

APL is most often treated with tretinoin and standard chemotherapy drugs. These chemotherapy drugs can cause infection and bleeding. They can also damage the heart and normal bone marrow cells. This can lead to a second leukemia years later.

In this study, the investigators are using tretinoin and arsenic trioxide together. Both drugs work to treat APL. They have been used together in only a limited number of people. The investigators want to use these drugs together to reduce the amount of standard chemotherapy and decrease side effects. The patient will receive standard chemotherapy with a drug called idarubicin only if they have a higher chance of the leukemia coming back or a higher risk of side effects.

Induction will consist of tretinoin 45 mg/m2 po daily (rounded up to the nearest 10mg) in two divided doses (25 mg/m2 in patients \<20 years of age) for 35 days and ATO 0.15 mg/kg IV daily for 35 doses given 5-7 days per week. The drugs will then be discontinued, and the patient will be followed until a clinical complete remission is achieved. Idarubicin 12 mg/m2 IV for 4 doses will be added during induction on day 2 if the presenting WBC is \>10,000/μl, or if the WBC increases to 5,000/μl on day 5, 10,000/μl on day 10, or 15,000/μl on day 15, because of the increased risk of the APL differentiation syndrome and relapse in these patients. Dexamethasone 10 mg twice daily with be given on days 1-14 of induction as prophylaxis for the APL differentiation syndrome. All patients will then receive four courses of consolidation with tretinoin 45 mg/m2 po daily (rounded up to the nearest 10mg) (25 mg/m2 in patients \<20 years of age) for 15 days and ATO 0.15 mg/kg IV for 25 doses.

Patients with high-risk disease or who received Idarubicin during Induction may receive intrathecal cytarabine as CNS prophylaxis given by the treating physician during consolidation, at the discretion of the site PI. High-risk patients will also receive maintenance therapy with additional courses of tretinoin and ATO every 3 months for 2 years. Each maintenance course will consist of tretinoin 45 mg/m2 po daily (25 mg/m2 in patients \<20 years of age) for 15 days and ATO 0.15 mg/kg IV for 10 doses. Disease status will be monitored with serial analyses of peripheral blood samples using RT-PCR for PML-RARα mRNA. Patients will be followed until relapse, death, loss to follow-up, or removal from study.

Induction therapy can be given as an inpatient or outpatient. Consolidation and maintenance treatments will be given as an outpatient. Consolidation may also be given at the patient's local institution. Intrathecal cytarabine treatments will be administered as an outpatient.

Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

after induction with combined tretinoin and ATO (along with idarubicin in patients with high-risk disease or who develop leukocytosis) in APL.

after induction with tretinoin and ATO (with idarubicin in patients with high-risk disease or who develop leukocytosis).

after each course of postremission therapy.

including the early death rate (within 30 days), the incidence of APL differentiation syndrome, the number and length of hospitalizations, the incidence of secondary myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), and the effects of treatment on left ventricular ejection fraction (LVEF) Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be tabulated.

with combined tretinoin and ATO using serial immunophenotyping studies of peripheral blood

by ATRA (Tretinoin) and ATO (Arsenic Trioxide). Bone marrow samples will be analyzed at baseline and at the time of clinical CR for telomerase activity, telomere length and TERT expression

Northwestern University

New York Presbyterian Hospital

University of Southern California

Princess Margaret Hospital, Canada

National Heart, Lung, and Blood Institute (NHLBI)

Memorial Sloan Kettering Cancer Center

This is a multicenter, phase II trial to study the efficacy of combined tretinoin and ATO in the treatment of newly diagnosed APL in an effort to reduce or eliminate the amount of standard chemotherapy required for long-term remission.

Tretinoin and Arsenic Trioxide: See Detailed Description

Age, Continuous

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Jae Park, MD

To Determine the Rate of Molecular Remission

Participants Who Experienced a Complete Remission

To Determine the Proportion of Patients in Molecular Remission

To Determine the Disease-free and Event-free Survival of Patients

To Determine the Toxicity of This Treatment Program

To Characterize the Differentiation of APL Cells During Treatment

Explore the in Vivo Induction of Telomerase-dependent Cell Death

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Neoplasms, Glandular and Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.

Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects

Taofeek Owonikoko, MD, PhD

The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in patients with small cell lung cancer who have failed at least one standard chemotherapy regimen as well as patients who are unable to tolerate the standard treatment for their cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide in this patient group. The study will include up to 36 participants with small cell lung cancer.

The investigators want to find out what effects, good or bad, that the study drug has on your cancer. This study will also look at specific biomarkers in your blood and in the tumor tissue which may help the investigators to determine if the levels of these biomarkers are related to tumor response to treatment.

Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more mature thereby stopping them from growing in number and more likely to die off.

Study of Arsenic Trioxide in Small Cell Lung Cancer

A Single Arm, Two-Stage Phase II Study of Arsenic Trioxide in Previously Treated Small Cell Lung Cancer

Response rate (complete response \[CR\]+ partial response \[PR\]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).

* Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
* Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
* Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
* Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis.

Defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Duration of time from enrollment on study until death

Cephalon

Teva Pharmaceuticals USA

National Cancer Institute (NCI)

Emory University

Associate Professor, Hematology/Medical Oncology, Principal Investigator

This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.

Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects

Arsenic Trioxide Treatment

Taofeek K. Owonikoko, MD, PhD, MSCR

Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.

Response Rate (RR)

An alternative endpoint of clinical benefit rate was pre-specified in the event that the study failed to meet its overall response rate (ORR) endpoint either at the end of stage I accrual or at final analysis. However, this study met its endpoint. Please see primary outcome measure 1.

Clinical Benefit Rate (CBR)

Progression-free Survival

Overall Survival

Bortezomib

Arm 1: Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Arm 2: Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Arm 3: Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).

Trisenox (Arsenic Trioxide)

Arm 1 (Level 1):

1.0 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).

Arm 2 (Level 2):

1.5 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).

Velcade (Bortezomib)

100 mg/m2 by vein days -4,-3, over 30 minutes

1000 mg once a day through the vein for 7 days.

Vitamin C (Ascorbic Acid)

Primary Objectives:

1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
3. To determine the effects of bortezomib on melphalan pharmacokinetics

Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma. Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die. Arsenic trioxide may cause cancer cells to die, and researchers want to find out if arsenic trioxide helps melphalan in killing cancer cells. Vitamin C makes arsenic trioxide more available inside the cancer cells, and researchers want to learn if Vitamin C makes arsenic trioxide more effective.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will have a dental exam to check for any infected teeth or gums that may flare up after chemotherapy.

You will have a bone marrow aspirate and biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Cytogenetic tests will be performed on the aspirate sample to look for any genetic abnormalities in your DNA. You will have x-rays of your bones taken. The study doctor will look at the x-rays to see if there are any myeloma-related bone changes. You will also have a chest x-ray.

You will have blood (about 2 tablespoons) and urine collected for routine tests. You will have a pulmonary function test, to check if your lungs are strong enough for high-dose chemotherapy. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will also have a MUGA scan to evaluate the function of your heart. Women who are able to have children must have a negative blood pregnancy test. The blood will be drawn as part of the 2 tablespoons drawn at screening.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of dice) to one of 3 treatment groups. There is an equal chance of being assigned to any of the 3 groups. All 3 groups will receive melphalan, arsenic trioxide, and Vitamin C. The second and third groups will also receive bortezomib, but at different dose levels. The first 3 participants assigned to receive bortezomib on this study will receive the lower of 2 bortezomib dose levels.

You will receive arsenic trioxide through a needle in a vein over 2 hours, once a day for 7 days (Days -9 to -3). At the same time, you will receive Vitamin C once a day through the vein for 7 days. After you receive the arsenic trioxide on Days -4 and -3, you will receive melphalan through the vein over 30 minutes.

If you are in Group 2 or 3, you will receive bortezomib by an intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).

You will receive standard inpatient and outpatient stem cell transplant care and testing. You will have to sign a separate consent form that describes the transplant procedure and its risks. Your stem cells will be reinfused 2 days after the last dose of melphalan. To check for any side effects, you will have an ECG performed 14 days after the transplant.

If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have already received melphalan and side effects occur, then the transplant will happen. However, if intolerable side effects develop before melphalan, then you may be taken off study without having the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant physician decides it is necessary.

If there is no sign of disease after the transplant, you will have routine follow-up visits. Blood (about 2 tablespoons) will be drawn for routine tests at least once a week during the first month after the transplant, and then once every month for the next 3 months after that. At about 3, 6, and 12 months after the transplant, you will have bone marrow biopsies and aspirates performed to check the status of the disease. You will have blood (about 2 tablespoons) and urine collected for routine tests. At 12 months after the transplant, you will have x-rays of your bones taken.

One (1) year after the transplant, your participation in this study will be over.

This is an investigational study. Bortezomib, arsenic trioxide, and melphalan are commercially available and FDA-approved for use in patients with myeloma. However, their use in combination with Vitamin C (also commercially available) is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients

Phase I/II Study of the Combination of Bortezomib With Arsenic Trioxide, Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma

Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with \<5% plasma cells, \<1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.

The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.

Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

No Bortezomib

Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Bortezomib 1.0 mg/m^2

Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Bortezomib 1.5 mg/m^2

Total

Muzaffar H. Qazilbash, MD/Professor, Stem Cell Transplantation

Number of Patients Reaching Complete Response (CR)

Time to Toxicity

For induction therapy, tamibarotene will be self-administered via tablets on an outpatient basis at a dose of 6 mg/m2 per day, taken orally, in two divided doses approximately one hour after breakfast and dinner. Induction therapy will continue for a maximum of 56 days until either a morphologic leukemia-free state or complete response (CR) has been achieved. For patients who achieve a CR with induction therapy, consolidation therapy will commence 4 to 8 weeks after the end of induction therapy. For patients who have a morphologic leukemia-free state after induction therapy but who fail to achieve a CR, consolidation therapy will commence 8 weeks after the end of induction therapy.

Tamibarotene

Jorge Cortes, MD

This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who are intolerant to either drug are eligible for this study.

Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL

A Phase II Study of Oral Tamibarotene in Acute Promyelocytic Leukemia Patients Who Have Received Prior Therapy With ATRA and Arsenic Trioxide (STAR-1)

CytRx

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Adenocarcinoma

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endothelial Growth Factors

Mitogens

Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.

Arsenic trioxide

Paola Gehrig, MD

The primary purpose of this study is to see whether women who have already received chemotherapy for their endometrial cancer, or who have disease that has spread outside of the uterus, will respond to the drug arsenic trioxide (Trisenox®) as judged by shrinkage of their tumor.

This is an open-label, single arm, single institution, phase II trial designed to assess the response rate and safety of Trisenox® in women with recurrent endometrial carcinoma. Trisenox® will be administered at a dose of 0.25 mg/kg/day for 5 consecutive days (D1-5) every 4 weeks. A 4-week period will be defined as a cycle of treatment. Marker and non-marker lesions will be assessed every 2 cycles (every 8 weeks) and the response assigned according to Gynecologic Oncology Group (GOG) RECIST guidelines. Safety will be assessed by routine physical, laboratory and ECG evaluations. Up to 10 patients will be enrolled into the study. Patients are expected (excluding any unforeseen toxicities) to receive a minimum of 2 and a maximum of 6 cycles of Trisenox®. (Patients with at least documented stable disease may be eligible for \>6 cycles). Patients will be followed for 6 months after their last dose of Trisenox®.

For this trial we would allow one prior cytotoxic regimen since the time of recurrence and patients may have had one prior regimen as part of their induction chemotherapy. Patients will be treated with 0.25 mg/kg/day for days 1-5 every 28 days and patients may remain on trial until progression of disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients	NCT00661544	Multiple Myelom... Stem Cell Trans...	Arsenic Trioxid... Melphalan Ascorbic Acid	- 70 Years	M.D. Anderson Cancer Center
Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia	NCT00675870	Acute Promyeloc...	NRX 195183 Soft...	18 Years -	NuRx Pharmaceuticals, Inc.
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy	NCT01404949	Acute Promyeloc...	Tretinoin and A...	18 Years -	Memorial Sloan Kettering Cancer Center
Study of Arsenic Trioxide in Small Cell Lung Cancer	NCT01470248	Lung Cancer Cancer of Lung Pulmonary Cance... Pulmonary Neopl... Carcinoma, Smal...	Arsenic Trioxid...	18 Years -	Emory University
Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients	NCT00661544	Multiple Myelom... Stem Cell Trans...	Arsenic Trioxid... Melphalan Ascorbic Acid	- 70 Years	M.D. Anderson Cancer Center
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients	NCT00469209	Myeloma	Trisenox (Arsen... Velcade (Bortez... Melphalan Vitamin C (Asco...	- 75 Years	M.D. Anderson Cancer Center
Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia	NCT00675870	Acute Promyeloc...	NRX 195183 Soft...	18 Years -	NuRx Pharmaceuticals, Inc.
Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL	NCT00520208	Acute Promyeloc...	Tamibarotene	18 Years -	CytRx
Trisenox® in Women With Metastatic Endometrial Cancer	NCT01184053	Endometrial Car...	Arsenic trioxid...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy	NCT01404949	Acute Promyeloc...	Tretinoin and A...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for trisenox

Every month we try and update this database with for trisenox 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 trisenox

Every month we try and update this database with for trisenox 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 trisenox 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.