NCT01590732

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

Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• 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

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Etoposide	Given IV
DRUG	Ifosfamide	Given IV
DRUG	Romidepsin	Given IV

Timeline

• Start date: 2012-10-29
• Primary completion: 2018-05-02
• Completion: 2018-05-02
• First posted: 2012-05-03
• Last updated: 2018-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study