Temsirolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
|ClinicalTrials.gov Identifier: NCT01902160|
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : November 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Adult Hodgkin Lymphoma||Drug: Brentuximab Vedotin Other: Laboratory Biomarker Analysis Drug: Temsirolimus||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Brentuximab Vedotin in Combination With Temsirolimus in Relapsed and Refractory Hodgkin Lymphoma|
|Study Start Date :||September 2013|
|Primary Completion Date :||May 2015|
U.S. FDA Resources
Experimental: Treatment (temsirolimus, brentuximab vedotin)
Patients receive temsirolimus 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.
Drug: Brentuximab Vedotin
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Temsirolimus
- MTD of temsirolimus, determined according to incidence of dose limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse v4.0 [ Time Frame: 21 days ]Toxicity will be reported using the Cancer Therapy Evaluation Program Adverse Event Reporting System.
- Changes in cytokine levels [ Time Frame: Baseline to day 1 of course 2 ]Descriptive statistics will be used to analyze the impact of cytokine levels on treatment response. Mean, standard deviation, median and range will be reported. Logistic regression will be used to evaluate the effects of the levels of serum cytokines/growth factors on treatment response.
- Overall response rate (sum of partial responses and complete responses) using the criteria developed by the International Harmonization Project for response assessment in lymphoma [ Time Frame: Up to 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902160
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Alison Moskowitz||Memorial Sloan Kettering Cancer Center|