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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

NCT01381692 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-10-04

Study results available
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Summary

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.

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

Interventions

DRUG

Bortezomib

Given IV or SC

DRUG

Dexamethasone

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

BIOLOGICAL

Rituximab

Given IV

DRUG

Temsirolimus

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Leonard T Heffner · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-20
Primary Completion
2014-12-08
Completion
2021-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01381692 on ClinicalTrials.gov