Lymphoma
Conditions
Keywords
AIDS-related primary CNS lymphoma
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALaldesleukin
DRUGganciclovir
DRUGzidovudine
Sponsors
National Cancer Institute (NCI)
AIDS Malignancy Consortium
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed