Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT00863369
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
  • gemcitabine hydrochloride — DRUG
    Given IV
  • questionnaire administration — OTHER
    Ancillary studies

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 gemcitabine hydrochloride, 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 gemcitabine hydrochloride and rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib and gemcitabine hydrochloride when given together with rituximab and to see how well they work in treating patients with progressive or relapsed B-cell non-Hodgkin lymphoma.

Key Dates

Start date
Jun 29, 2005
Status verified
Mar 2023
Primary completion
Aug 25, 2016
Completion
Jun 20, 2023

Study Design

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

Arms

  • Experimental: Treatment (bortezomib, gemcitabine hydrochloride, rituximab)
    Patients receive bortezomib IV, gemcitabine hydrochloride IV over 3-4 hours, and rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With at Least One Dose Limiting Toxicity (DLT) [ Time Frame: 28 days from start of treatment, up to 2 years. ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-3000-
South Pasadena Cancer CenterSouth PasadenaCalifornia91030-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CASouth Pasadena Cancer Center· South Pasadena, CA

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