Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma

PRIMARY OBJECTIVES:

I. To assess the safety profile of romidepsin given before and after ifosfamide, carboplatin, etoposide (ICE) chemotherapy for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

II. To determine the maximum tolerated dose (MTD), if reached, of romidepsin administered in combination with ICE chemotherapy in patients with relapsed or refractory PTCL.

SECONDARY OBJECTIVES:

I. To determine the overall response rate (ORR) and complete response (CR) rate in patients with relapsed or refractory PTCL.

OUTLINE: This is a dose-escalation study of romidepsin.

Participants receive romidepsin intravenously (IV) over 4 hours on days 1 and 4, ifosfamide IV over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on day 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up within 2-4 weeks.

Inclusion criteria

• Relapsed or refractory T cell lymphoma (TCL) status including diagnoses of peripheral TCL-not otherwise specified (NOS), angioimmunoblastic TCL, anaplastic large cell lymphoma, hepatosplenic TCL, enteropathy-associated TCL, or mycosis fungoides(MF)/cutaneous TCL with transformation to systemic TCL
• Patients must have received at least one chemotherapy regimen which contained doxorubicin
• At least one 1.5 cm bidimensional measurable lesion or bone marrow positivity of TCL
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• 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 upper limit of normal [ULN])
• Creatinine =< 1.5 x ULN
• Alanine aminotransferase (ALT) and aminotransferase (AST) =< 3 x ULN
• 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
• 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

• History of another malignancy not in remission for at least 2 years (yrs) (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ)
• Known active Central Nervous System (CNS) lymphoma
• Ejection fraction (EF) of < 40%, myocardial infarction (MI) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrthymias, or electrocardiogram (ECG) evidence of acute ischemia
• Grade 3 infection within 2 weeks of first dose romidepsin plus ICE
• Pregnant or lactating
• Receipt of another investigational drug within 14 days of enrollment
• Patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone)