Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma

AIDS Malignancy Consortium

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Treatments

Drug: ganciclovir

Biological: aldesleukin

Drug: zidovudine

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00006264

AMC-019

CDR0000068204 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: