Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00003595
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • filgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • CHOP regimen — DRUG
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • prednisone — DRUG
  • vincristine sulfate — DRUG

Study Details

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have previously untreated HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus monoclonal antibody therapy is more effective than combination chemotherapy alone in treating HIV-associated non-Hodgkin's lymphoma.

Key Dates

Start date
Jan 31, 1999
Status verified
May 2007
Primary completion
Apr 30, 2006

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 3 and oral prednisone on days 3-7. Patients receive rituximab on day 1. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response in the absence of disease progression or unacceptable toxicity. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy with rituximab followed by radiotherapy beginning 3 weeks after completion of the third course. Patients who achieve partial response for a minimum of 28 days or complete response receive maintenance rituximab IV beginning on day 28 of the final course of chemotherapy. Maintenance rituximab treatment repeats every 4 weeks for 3 courses.
  • Active Comparator: Arm II
    Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy. Patients receive radiotherapy beginning 3 weeks after completion of the third course of chemotherapy.

Locations (13)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensive Cancer Center, UCLALos AngelesCalifornia90095-1781-
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90033-0804-
San Francisco General Hospital Medical CenterSan FranciscoCalifornia94110-
Sylvester Cancer Center, University of MiamiMiamiFlorida33136-
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicagoIllinois60611-3013-
Massachusetts General HospitalBostonMassachusetts02114-2617-
University Hospital/New Jersey Cancer CenterNewarkNew Jersey07103-
Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-
Mount Sinai School of MedicineNew YorkNew York10029-
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew YorkNew York10016-
Ireland Cancer CenterClevelandOhio44106-5065-
Arthur G. James Cancer Hospital - Ohio State UniversityColumbusOhio43210-1240-

Find similar trials in Los Angeles, CA

By research site
Jonsson Comprehensive Cancer Center, UCLA· Los Angeles, CAUSC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CASan Francisco General Hospital Medical Center· San Francisco, CASylvester Cancer Center, University of Miami· Miami, FLRobert H. Lurie Comprehensive Cancer Center, Northwestern University· Chicago, ILMassachusetts General Hospital· Boston, MA

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