NCT01738594

Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma

A Randomized Phase I Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase I trial studies the side effects and the best dose of carfilzomib when given together with or without romidepsin in treating patients with stage IA-IVB cutaneous T-cell lymphoma. Carfilzomib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carfilzomib alone is more effective than when given together with romidepsin.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of carfilzomib, both as a single agent as well as in combination with romidepsin, in patients with cutaneous T-cell lymphoma (CTCL). SECONDARY OBJECTIVES: I. Overall response rate (ORR). II. Duration of response. III. Time to progression (TTP). TERTIARY OBJECTIVES: I. Measure proteasome activity concurrently in peripheral blood mononuclear cells (PBMCs) and tumor tissue biopsy specimens in order to gather pilot data on proteasome inhibition in CTCL patients treated with carfilzomib alone as well as carfilzomib with romidepsin. OUTLINE: This is a dose-escalation study of carfilzomib. Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and 16. ARM B: Patients receive carfilzomib as in Arm A and romidepsin IV over 4 hours on days 1, 8, and 15. In both arms, treatment repeats every 28 days for at least 2-4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Conditions

• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IA Mycosis Fungoides/Sezary Syndrome
• Stage IB Mycosis Fungoides/Sezary Syndrome
• Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IIA Mycosis Fungoides/Sezary Syndrome
• Stage IIB Mycosis Fungoides/Sezary Syndrome
• Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IIIA Mycosis Fungoides/Sezary Syndrome
• Stage IIIB Mycosis Fungoides/Sezary Syndrome
• Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IVA Mycosis Fungoides/Sezary Syndrome
• Stage IVB Mycosis Fungoides/Sezary Syndrome

Interventions

Type	Name	Description
DRUG	carfilzomib	Given IV
DRUG	romidepsin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-03-22
• Primary completion: 2016-10-11
• Completion: 2016-10-11
• First posted: 2012-11-30
• Last updated: 2019-08-29
• Results posted: 2019-08-29

Locations

1 site across 1 country: United States