Recurrent Marginal Zone Lymphoma Clinical Trial
Official title:
Phase I/II Investigation of Temsirolimus Plus Lenalidomide in Relapsed Non-Hodgkin Lymphomas
This phase I/II trial studies the side effects and the best dose of lenalidomide when given together with temsirolimus and to see how well it works in treating patients with Hodgkin lymphoma or non-Hodgkin lymphoma that has come back after a period of improvement or is not responding to treatment. 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.
PRIMARY OBJECTIVES:
I. To determine the safety, toxicity, and maximum tolerated dose of lenalidomide when
combined with temsirolimus in patients with relapsed lymphomas. (Phase I) II. To determine
complete and overall response rate of lenalidomide plus temsirolimus in patients with
relapsed lymphomas as stratified by histology: follicular lymphoma, diffuse large B-cell
lymphoma, and lymphoma not otherwise specified (NOS) (including Hodgkin lymphoma, T-cell
non-Hodgkin lymphoma [T-NHL], lymphoplasmacytic lymphoma, and mantle cell lymphoma). (Phase
II) III. To determine duration of response, progression-free survival, and overall survival
of lenalidomide plus temsirolimus in patients with relapsed lymphomas as stratified by
histology: diffuse large B-cell lymphoma, follicular lymphoma, and lymphoma NOS (including
Hodgkin lymphoma, T-NHL, lymphoplasmacytic lymphoma, mantle cell lymphoma). (Phase II)
SECONDARY OBJECTIVES:
I. To determine mammalian target of rapamycin (mTOR) pathway activation in pre-treatment
tumor tissue.
II. To determine angiogenic and microenvironmental status of pre-treatment tissue and
peripheral blood samples, and to evaluate changes following treatment with temsirolimus and
lenalidomide.
III. To determine differentially expressed genes associated with differences in clinical
response and in progression-free survival (PFS) in patients with diffuse large B-cell
lymphoma (DLBCL) and follicular lymphoma (FL) (Groups A and B, respectively).
IV. To determine a methylation signature predictive of clinical response and PFS in patients
with DLBCL and FL (Groups A and B, respectively).
OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II
study.
Patients receive lenalidomide orally (PO) on days 1-21 and temsirolimus intravenously (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.
After completion of study treatment, patients are followed up for 1 year.
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