This trial is active, not recruiting.

Condition lymphoma
Treatments bleomycin sulfate, rituximab, prednisolone, vincristine sulfate
Phase phase 1
Target CD20
Sponsor Lymphoma Trials Office
Start date October 2001
Trial identifier NCT00031902, BNLI-POORRISKHIV, CDR0000069238, EU-20145


RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL) - Previously untreated - More than 1 of the following criteria: - Prior diagnosis of AIDS - ECOG performance status 3-4 - CD4 count less than 100/mm3 - No primary cerebral lymphoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - See Disease Characteristics Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for HIV-NHL - At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS) Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy for HIV-NHL allowed - At least 1 year since prior radiotherapy for KS Surgery: - Not specified

Additional Information

Official title Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma
Description OBJECTIVES: - Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin. - Determine the toxicity of this regimen in these patients. - Determine the time to progression and survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR. Patients are followed every 1-2 months. PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).