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RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of Hodgkin lymphoma or non-Hodgkin lymphoma by blocking blood flow to the cancer. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and the best dose of lenalidomide when given together with temsirolimus to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.
- To determine the maximum-tolerated dose of lenalidomide when combined with temsirolimus in patients with relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma. (Phase I)
- To determine the safety and toxicity of this regimen in these patients. (Phase I)
- To determine the complete and overall response rate in patients treated with this regimen. (Phase II)
- To determine duration of response in patients treated with this regimen. (Phase II)
- To determine the progression-free survival and overall survival of patients treated with this regimen. (Phase II)
- To determine mTOR pathway activation in pre-treatment tumor tissue.
- To determine the angiogenic and microenvironmental status of pre-treatment tissue and peripheral blood samples, and to evaluate changes following treatment with this regimen.
OUTLINE: This is a multicenter, phase I, dose-escalation study of lenalidomide followed by a phase II study. Patients in the phase II portion are stratified according to non-Hodgkin lymphoma (NHL) histology (diffuse large-B-cell lymphoma vs follicular lymphoma vs lymphoma not otherwise specified [Hodgkin lymphoma, T-NHL, marginal zone lymphoma, and lymphoplasmacytic lymphoma]).
Patients receive oral lenalidomide on days 1-21 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses may continue therapy for up to 52 weeks.
Some patients undergo blood samples collection at baseline and periodically during study for laboratory analysis. Tumor tissues from biopsies are also analyzed.
Masking: Open Label, Primary Purpose: Treatment
lenalidomide, temsirolimus, laboratory biomarker analysis
University of Chicago Cancer Research Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:15:36-0400
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