Clinical Trials

Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma

Location:

Rochester, MN

Trial status:

Open for Enrollment

Why is this study being done?

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of temsirolimus in combination with bortezomib, rituximab, dexamethasone in patients with relapsed Waldenstrom's Macroglobulinemia and relapsed/refractory mantle cell, follicular, marginal zone or small lymphocytic lymphoma. (Phase I) II. To evaluate whether the addition of temsirolimus to the regimen of bortezomib, rituximab, dexamethasone improves progression-free survival in patients with previously untreated or relapsed Waldenstrom's Macroglobulinemia. (Phase II) SECONDARY OBJECTIVES: I. To define and describe the toxicities of temsirolimus in combination with bortezomib, rituximab, and dexamethasone. (Phase I) II. To evaluate time to progression of bortezomib, rituximab, dexamethasone +/- temsirolimus in patients. (Phase II) III. To evaluate major and minor response by 6 cycles of therapy of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) IV. To evaluate time to response and duration of response of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) V. To evaluate toxicity of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) VI. To evaluate time to next therapy of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) VII. To evaluate overall survival of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Phase II) VIII. To describe treatment-related fatigue, physical and functional well-being during and after treatment. (Phase II) IX. To compare the change in treatment related fatigue, physical and functional well-being over 6 cycles of bortezomib, rituximab, dexamethasone +/- temsirolimus. (Quality of Life) X. To prospectively assess health-related quality of life longitudinally (pre-treatment to 3 year follow-up assessment) among trial participants. (Quality of Life) XI. To describe treatment-related peripheral neuropathy associated with bortezomib neurotoxicity. (Quality of Life) OUTLINE: This is a multicenter, phase I, dose-escalation study of temsirolimus followed by a phase II study. PHASE I: Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22; rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only); and bortezomib IV and dexamethasone orally (PO) on days 1, 8, and 15. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are stratified according to disease status (previously untreated vs relapsed) and by the International Prognostic Scoring System for Waldenstrom macroglobulinemia staging (stage I or II vs stage III). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive rituximab intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV and dexamethasone orally (PO) on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm I. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients complete the Functional Assessment of Cancer Therapy (FACT) Physical well-being scale, the Functional well-being scale, and the FACT-Fatigue scale at baseline and periodically during study. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 5 years, and then yearly for 5 years.

Last updated: 05/06/2013

NCT ID:

NCT01381692