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Clinical Trial: Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| AIDS-related peripheral/systemic lymphoma AIDS-related diffuse large cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related small noncleaved cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related lymphoblastic lymphoma | Drug: bleomycin Drug: prednisolone Drug: rituximab Drug: vincristine Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: monoclonal antibody therapy | Phase I |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Pilot Study of Rituximab Combined With Prednisolone, Vincristine, and Bleomycin in Patients With Poor-Prognosis, HIV-Related Non-Hodgkin's Lymphoma
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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
Location Information
United Kingdom
Chelsea Westminster Hospital, London, SW10 9NH, United Kingdom
United Kingdom, England
St. George's Hospital, London, England, SW17 0QT, United Kingdom
Ruth Pettengell, MD, Study Chair, St. George's Hospital
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2003
Last Updated: October 13, 2004
Record first received: March 8, 2002
ClinicalTrials.gov Identifier: NCT00031902
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- What Is Fetal Alcohol Syndrome? (MayoClinic)

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