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

Conditions

• Recurrent Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Small Lymphocytic Lymphoma
• Recurrent Waldenstrom Macroglobulinemia
• Refractory Follicular Lymphoma
• Refractory Mantle Cell Lymphoma
• Refractory Marginal Zone Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Small Lymphocytic Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bortezomib — DRUG
  Given IV or SC
• Dexamethasone — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Rituximab — BIOLOGICAL
  Given IV
• Temsirolimus — DRUG
  Given IV

Study Details

This randomized phase I/II trial studies the side effects and the best dose of temsirolimus when given together with bortezomib, rituximab, and dexamethasone and to see how well they work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether bortezomib, rituximab, and dexamethasone are more effective with temsirolimus in treating non-Hodgkin lymphoma.

Key Dates

Start date

Jul 20, 2011

Status verified

Sep 2021

Primary completion

Dec 8, 2014

Completion

Sep 1, 2021

Study Design

Enrollment

9 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (rituximab, bortezomib, dexamethasone)
  Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (temsirolimus, rituximab, bortezomib, dexamethasone)
  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.

Primary Outcome Measure

Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone [ Time Frame: Assessed during cycle 1 (28 days) ]

Locations (11)

Find similar trials in Denver, CO

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