Recurrent Adult Hodgkin Lymphoma Clinical Trial
Official title:
A Phase 1 Study of Brentuximab Vedotin in Combination With Temsirolimus in Relapsed and Refractory Hodgkin Lymphoma
This phase I trial studies the side effects and best dose of temsirolimus when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned or has not responded to treatment. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing. Giving temsirolimus with brentuximab vedotin may work better in treating patients with Hodgkin lymphoma.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of temsirolimus in combination with
brentuximab vedotin in patients with relapsed and refractory Hodgkin lymphoma.
II. To assess the safety of brentuximab vedotin in combination with temsirolimus in patients
with relapsed and refractory Hodgkin lymphoma.
III. To assess the toxicity profile of this regimen in the above patients.
SECONDARY OBJECTIVES:
I. Determine the overall response rate (ORR) to the combination of brentuximab vedotin and
temsirolimus in relapsed and refractory Hodgkin lymphoma.
II. Evaluate the role of inflammatory markers, such as interleukin (IL)-6, IL-1, tumor
necrosis factor alpha (TNF alpha), and IL-10, as early predictors of treatment response.
OUTLINE: This is a dose-escalation study of temsirolimus.
Patients receive temsirolimus intravenously (IV) over 30-60 minutes on days 1 and 8 or days
1, 8, and 15 and brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21
days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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