A Phase II Trial Of Induction Therapy With Zidovudine, Interleukin-2, And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma
- Determine the safety and toxicity of zidovudine, interleukin-2, and ganciclovir in
patients with AIDS related primary central nervous system lymphoma.
- Determine the response rate and overall survival of these patients treated with this
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive zidovudine (AZT) IV and ganciclovir IV over 1 hour
every 12 hours on days 1-14. Patients also receive interleukin-2 (IL-2) IV every 12
hours on days 1-14 and a combination antiretroviral therapy consisting of nucleoside
reverse transcriptase inhibitors (one of which must be AZT), nonnucleoside reverse
transcriptase inhibitors, and protease inhibitors. AZT and ganciclovir treatment
continues for an additional 7 days if partial response is achieved.
- Maintenance therapy: Patients receive IL-2 subcutaneously 3 times a week for 6 months.
Patients also receive oral ganciclovir 3 times a day and combination antiretroviral
therapy (AZT allowed, but not required). Treatment continues in the absence of disease
progression or unacceptable toxicity.
Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6
PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.
Primary Purpose: Treatment
William J. Harrington, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Federal Government
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Sylvester Cancer Center, University of Miami||Miami, Florida 33136|