Overview

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

Status:
Completed
Trial end date:
2018-05-02
Target enrollment:
0
Participant gender:
All
Summary
This phase I trial studies the best dose and side effects of romidepsin when given in combination with ifosfamide, carboplatin, and etoposide in treating participants with peripheral T-cell lymphoma that has come back or does not respond to treatment. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving romidepsin, ifosfamide, carboplatin, and etoposide may work better in treating participants with peripheral T-cell lymphoma.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Celgene Corporation
National Cancer Institute (NCI)
Treatments:
Anti-Bacterial Agents
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Mesna
Podophyllotoxin
Romidepsin
Criteria
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)