Bortezomib and Fludarabine With or Without Rituximab in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Part of paid clinical trials in Canton, Ohio.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00068315
Phase
PHASE1
Status
Completed

Conditions

  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hematopoietic/Lymphoid Cancer
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia

Eligibility Criteria

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

Interventions

  • bortezomib — DRUG
    Given IV
  • fludarabine phosphate — DRUG
    Given IV
  • rituximab — BIOLOGICAL
    Given IV

Study Details

This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine with or without rituximab in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 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 fludarabine with or without rituximab may kill more cancer cells.

Key Dates

Start date
Jul 31, 2003
Status verified
Sep 2013
Primary completion
Dec 31, 2008

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (bortezomib, fludarabine, rituximab)
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and fludarabine IV over 30 minutes on days 1-3 or 1-5. Patients may also receive rituximab IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria version 2.0 [ Time Frame: 3 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mercy Medical CenterCantonOhio44708-
Case Western Reserve UniversityClevelandOhio44106-
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-
Southwest General Health Center Ireland Cancer CenterMiddleburg HeightsOhio44130-
UHHS-Chagrin Highlands Medical CenterOrangeOhio44122-
University Suburban Medical CenterSouth EuclidOhio44121-
UHHS-Westlake Medical CenterWestlakeOhio44145-

Find similar trials in Canton, OH

By research site
Mercy Medical Center· Canton, OHCase Western Reserve University· Cleveland, OHSeidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center· Cleveland, OHSouthwest General Health Center Ireland Cancer Center· Middleburg Heights, OHUHHS-Chagrin Highlands Medical Center· Orange, OHUniversity Suburban Medical Center· South Euclid, OH

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