Trial Information

Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related 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.