Phase I Study of Romidepsin Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
This trial is active, not recruiting.
|Treatments||romidepsin, ifosfamide, mesna, carboplatin, etoposide|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||October 2012|
|End date||October 2018|
|Trial size||22 participants|
|Trial identifier||NCT01590732, 2012-0183, NCI-2012-00847|
The goal of this clinical research study is find the highest tolerable dose of romidepsin that can be given in combination with ifosfamide, carboplatin, etoposide (ICE) to patients with PTCL. The safety of this drug combination will also be studied.
Romidepsin is designed to stop the growth of cancer cells and block new blood vessels from forming around the cancer cells. This may cause the cancer cells to die.
Ifosfamide and etoposide are designed to slow or stop the growth of cancer cells.
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Maximum Tolerated Dose (MTD) of Romidepsin Plus ICE
time frame: 21 days
Overall Response Rate (ORR) of Romidepsin Plus ICE
time frame: 14 days after the last dose of study drug
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Relapsed or refractory TCL status including diagnoses of peripheral TCL-NOS, angioimmunoblastic TCL, anaplastic large cell lymphoma, hepatosplenic TCL, enteropathy-associated TCL, or mycosis fungoides(MF)/cutaneous TCL with transformation to systemic TCL. 2. Patients must have received at least one chemotherapy regimen which contained doxorubicin. 3. At least one 1.5 cm bidimensional measurable lesion or bone marrow positivity of TCL. 4. Eastern Cooperative Oncology Group (ECOG) performance status = 2. 5. Lab criteria of absolute neutrophil count (ANC) >/= 1000 cells/mm3, platelets >/= 80,000 cells/mm3 if baseline bone marrow negative for TCL involvement and platelets >/= 20,000 cells/mm3 if baseline bone marrow positive for TCL involvement, bilirubin = 2 x upper limits of normal (ULN) (Gilbert's = 3 x ULN), creatinine = 1.5 x ULN, and ALT and AST = 3 x ULN. 6. Negative pregnancy test for females of childbearing potential within 7 days prior to start of treatment. Patients of reproductive potential must follow accepted birth control methods which include hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during treatment and for 3 months after completion of treatment. 7. Age of >/= 18 years. 8. Voluntarily signed Institutional Review Board (IRB) approved informed consent document (ICD) before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: 1. History of another malignancy not in remission for at least 2 yrs (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ) 2. Known active Central Nervous System (CNS) lymphoma. 3. Ejection fraction (EF) of < 40%, myocardial infarction (MI) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrythmias, or ECG evidence of acute ischemia. 4. Grade 3 infection within 2 weeks of first dose romidepsin plus ICE. 5. Pregnant or lactating. 6. Receipt of another investigational drug within 14 days of enrollment. 7. Patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone).
|Official title||Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma|
|Principal investigator||Michelle A. Fanale, MD|
|Description||Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a dose level of romidepsin based on when you join this study. Up to 4 dose levels of romidepsin will be tested. Between 3-10 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 romidepsin is found. All participants will receive the same dose level of ifosfamide, carboplatin, and etoposide. Study Drug Administration: Each Cycle is 14 days. On Day 1: - You will receive romidepsin by vein over 4 hours. - You will receive ifosfamide by vein over 24 hours. - You will receive mesna by vein over 24 hours. This infusion will begin 12 hours after the end of the ifosfamide infusion. Mesna is given to help reduce the risk of bladder-related side effects. - You will receive carboplatin by vein over 1 hour. - You will receive etoposide by vein over 2 hours. On Days 2-3, you will receive etoposide by vein over 2 hours. On Day 4, you will receive romidepsin by vein over 4 hours. If needed, you will receive magnesium and potassium replacements. Study Visits: On Day 1 of every cycle: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - You will have an ECG. - You will be asked about any side effects you may be having. Every week, blood (about 2 tablespoons) will be drawn for routine tests. Between Days 7-14 of Cycles 2, 4, and 6, you may have a CT and PET/CT to check the status of the disease. Length of Study Drug Administration: You may receive up to 6 cycles. You will no longer be able to take the study drug combination 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-study visit. End-of-Study Visit: About 14 days after the last dose of study drug: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - You may have a CT and PET/CT to check the status of the disease. - You may have a bone marrow biopsy/aspirate to check the status of the disease. - You will have an ECG. - You will be asked about any side effects you may be having. This is an investigational study. Romidepsin is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least 1 prior systemic therapy. ICE is FDA approved and commercially available for the treatment of several types of lymphoma, including relapsed and refractory Hodgkin's lymphoma. The combination of romidepsin and ICE for the treatment of PTCL is investigational. Up to 30 participants will take part in this study. All will be enrolled at MD Anderson.|
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