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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-29

Study Completion Date

2018-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas

NCT01280526

Peripheral T Cell Lymphoma

COMPLETED PHASE1/PHASE2

Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas

NCT02181218

Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral Hodgkin Disease +1 more

COMPLETED PHASE1

Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma

NCT01445340

Mycosis Fungoides Cutaneous T-Cell Lymphoma Neoplasms

TERMINATED PHASE1

Depsipeptide in Treating Patients With Solid Tumors

NCT00019318

Lymphoma

COMPLETED PHASE1

FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT00383565

Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Mantle Cell Lymphoma

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mycosis Fungoides Recurrent Anaplastic Large Cell Lymphoma Recurrent Angioimmunoblastic T-Cell Lymphoma Recurrent Enteropathy-Associated T-Cell Lymphoma Recurrent Hepatosplenic T-Cell Lymphoma Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified Refractory Anaplastic Large Cell Lymphoma Refractory Angioimmunoblastic T-Cell Lymphoma Refractory Enteropathy-Associated T-Cell Lymphoma Refractory Hepatosplenic T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (romidepsin, ifosfamide, carboplatin, etoposide)

Participants receive romidepsin 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.

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

Given IV

Etoposide

Intervention Type DRUG

Given IV

Ifosfamide

Intervention Type DRUG

Given IV

Romidepsin

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carboplatin

Given IV

Intervention Type DRUG

Etoposide

Given IV

Intervention Type DRUG

Ifosfamide

Given IV

Intervention Type DRUG

Romidepsin

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Demethyl Epipodophyllotoxin Ethylidine Glucoside EPEG Lastet Toposar Vepesid VP 16-213 VP-16 VP-16-213 Asta Z 4942 Asta Z-4942 Cyfos Holoxan Holoxane Ifex IFO IFO-Cell Ifolem Ifomida Ifomide Ifosfamidum Ifoxan IFX Iphosphamid Iphosphamide Iso-Endoxan Isoendoxan Isophosphamide Mitoxana MJF 9325 MJF-9325 Naxamide Seromida Tronoxal Z 4942 Z-4942 Antibiotic FR 901228 Depsipeptide FK228 FR901228 Istodax N-[(3S,4E)-3-Hydroxy-7-mercapto-1-oxo-4-heptenyl]-D-valyl-D-cysteinyl-(2Z)-2-amino-2-butenoyl-L-valine, (4->1) Lactone, Cyclic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No