This phase I trial studies the best dose and side effects of romidepsin when given together with brentuximab vedotin in treating patients with cutaneous T-cell lymphoma. Romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Giving romidepsin and brentuximab vedotin together may work better in treating patients with cutaneous T-cell lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02616965.
PRIMARY OBJECTIVE:
I. To identify the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of the combination of brentuximab vedotin and romidepsin for patients with cutaneous T-cell lymphoma (CTCL).
SECONDARY OBJECTIVES:
I. To assess the overall safety and tolerability of the combination of brentuximab vedotin (BV) & romidepsin.
II. To estimate the response rate (rate of complete and partial response; overall response rate [ORR = complete response (CR) + partial response (PR)]) of the combination treatment.
III. To estimate duration of response.
IV. To assess changes quality of life using the Skindex-16 questionnaire.
V. To estimate patient survival for the combination treatment.
EXPLORATORY OBJECTIVES:
I. To assess the association of CD30 expression and treatment response.
II. To assess changes in CD30 expression after 1 dose of romidepsin treatment.
III. To assess biomarkers for treatment response using Nanostring.
OUTLINE: This is a dose-escalation study of romidepsin.
Patients receive romidepsin intravenously (IV) over 4 hours on day -14. Beginning in cycle 1, patients receive romidepsin IV over 4 hours on days 1 and 15 or days 1, 8, and 15, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and every 12 weeks for 2 years.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorShazia Nakhoda