Lymphoma Clinical Trial
Official title:
Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma
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.
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.
;
Primary Purpose: Treatment
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