Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00295932
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • bortezomib — DRUG
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • prednisone — DRUG
    Given orally

Study Details

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different 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. Giving bortezomib together with cyclophosphamide, prednisone, and rituximab may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of bortezomib when given together with cyclophosphamide, prednisone, and rituximab and to see how well it works in treating patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma.

Key Dates

Start date
Dec 13, 2005
Status verified
Mar 2018
Primary completion
Mar 11, 2018
Completion
Mar 11, 2018

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2, 5, 9, and 12. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II
    Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 2 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Memorial Sloan-Kettering at Basking RidgeBasking RidgeNew Jersey07920-
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08903-
Memorial Sloan-Kettering Cancer Center @ SuffolkCommackNew York11725-
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan-Kettering at Mercy Medical CenterRockville CentreNew York--
Memoral Sloan Kettering Cancer Center@PhelpsSleepy HollowNew York--

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Winship Cancer Institute of Emory University· Atlanta, GAMemorial Sloan-Kettering at Basking Ridge· Basking Ridge, NJCancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School· New Brunswick, NJMemorial Sloan-Kettering Cancer Center @ Suffolk· Commack, NYHerbert Irving Comprehensive Cancer Center at Columbia University Medical Center· New York, NYMemorial Sloan-Kettering Cancer Center· New York, NY

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