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Home > "R" Clinical Trials Conditions > Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma  Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
For Condition: AIDS-related diffuse large cell lymphoma,AIDS-related immunoblastic large cell lymphoma,AIDS-related lymphoblastic lymphoma,AIDS-related peripheral/systemic lymphoma,AIDS-related diffuse small cleaved cell lymphoma,AIDS-related diffuse mixed cell lymphoma,AIDS-related small noncleaved cell lymphoma
Status: No longer recruiting
Sponsor(s): British National Lymphoma Investigation ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RuthPettengell, Study Chair, St. George's Hospital
St. George's Hospital
London, England, SW17 0QT
United Kingdom
Chelsea Westminster Hospital
London, , SW10 9NH
United Kingdom
Additional Information:
Study ID Numbers: CDR0000069238; BNLI-POORRISKHIV,EU-20145
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031902
Other Aids-Related Small Noncleaved Cell Lymphoma Studies:
1. Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
2. Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
3. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma
4. Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma
5. Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Related Studies:
Other AIDS-related small noncleaved cell lymphoma Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
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