NCT01902160

Temsirolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

A Phase 1 Study of Brentuximab Vedotin in Combination With Temsirolimus in Relapsed and Refractory Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Adult Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Temsirolimus	Given IV

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-05-01
• First posted: 2013-07-18
• Last updated: 2015-11-09

Locations

1 site across 1 country: United States