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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma  Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
For Condition: AIDS-Related Lymphoma
Status: Recruiting
Sponsor(s): British National Lymphoma Investigation ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis HIV-related non-Hodgkin's lymphoma. - Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients. OUTLINE: This is a multicenter study. Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 15-30 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: - Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following: - Prior diagnosis of acquired immune deficiency syndrome (AIDS) - CD4 count greater than 100,000/mm3 - ECOG 3-4 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - See Disease Characteristics Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic: - Not specified Chemotherapy: - Not specified Endocrine: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RuthPettengell, Study Chair, St. Georges Hospital Medical School
Western General Hospital *Recruiting*
Edinburgh, Scotland, EH4 2XU
United Kingdom
Recruiting John Davies 44-131-537-1000
King's College Hospital *Recruiting*
London, England, NW1 2DA
United Kingdom
Recruiting Steve Devereux 207-679-8060
Cheltenham General Hospital *Recruiting*
Cheltenham, England, GL53 7AN
United Kingdom
Recruiting Sean Elyan 44-1242-22-2222
St. Georges Hospital Medical School *Recruiting*
London, England, SW17 ORE
United Kingdom
Recruiting Ruth Pettengell 44-20-8725-5454
Additional Information:
Study ID Numbers: CDR0000069261; BNLI-GOODRISKHIV,EU-20144
Study Start Date:
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032149
Other Aids-Related Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease
2. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
3. Treatment for Chronic Pain in Patients With Advanced Cancer
4. Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
5. Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
Related Studies:
Other AIDS-Related Lymphoma Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
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