Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00032149
- Lead Sponsor
- Lymphoma Trials Office
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicity Effects of treatment on response rate, time to disease progression, and survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
King's College Hospital
🇬🇧London, England, United Kingdom
St. Georges, University of London
🇬🇧London, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom