zidovudine plus interleukin-2 and ganciclovir in treating patients with aids-related primary central nervous system lymphoma

Conditions: Lymphoma

Summary: rationale: antiviral drugs such as zidovudine and ganciclovir act against viruses and may be an effective treatment for hiv. interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells. combining these treatments may be effective in treating aids-related primary central nervous system lymphoma. purpose: phase ii trial to study the effectiveness of combining zidovudine, ganciclovir, and interleukin-2 in treating patients who have aids-related primary central nervous system lymphoma.

objectives: * 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 regimen. 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 months thereafter. projected accrual: a total of 10-30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * hiv positive * diagnosis of central nervous system lymphoma by one of the following means: * brain biopsy * thallium spectroscopy scan in conjunction with ct scan or mri after failing to improve with at least 2 weeks of antitoxoplasmosis therapy * cerebral spinal fluid positive for epstein barr virus in conjunction with positive thallium spectroscopy scan * thallium spectroscopy scan demonstrating a thallium retention index greater than 1 * documented intracranial space occupying lesion * no systemic non-hodgkin's lymphoma patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * not specified hematopoietic: * absolute granulocyte count at least 1,000/mm3 * platelet count at least 50,000/mm3 hepatic: * bilirubin and sgot no greater than 3 times upper limit of normal * no major hepatic dysfunction as evidenced by encephalopathy, ascites, or varices renal: * creatinine clearance at least 60 ml/min other: * no prior other malignancy within the past 5 years except carcinoma in situ of the cervix, basal cell carcinoma of the skin, or kaposi's sarcoma not requiring systemic therapy * no active uncontrolled infection except hiv or epstein barr virus * no known allergy to e. coli derived products * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * not specified surgery: * not specified

Keywords: aids-related primary cns lymphoma