Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. Determine the safety and toxicity of zidovudine, interleukin-2, and ganciclovir in patients with AIDS related primary central nervous system lymphoma.
2. Determine the response rate and overall survival of these patients treated with this regimen.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• Not specified

Surgery:

• Not specified

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

Expected Enrollment

A total of 10-30 patients will be accrued for this study.

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.

Aboulafia DM, Ratner L, Miles SA, et al.: Antiviral and immunomodulatory treatment for AIDS-related primary central nervous system lymphoma: AIDS Malignancies Consortium pilot study 019. Clin Lymphoma Myeloma 6 (5): 399-402, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

AIDS Associated Malignancies Clinical Trials Consortium

William Harrington, MD, Protocol chair		Ph: 305-243-4994 Email: wharring@med.miami.edu

Registry Information
Official Title		A Phase II Trial Of Induction Therapy With Zidovudine, Interleukin-2, And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma
Trial Start Date		2000-07-28
Registered in ClinicalTrials.gov		NCT00006264
Date Submitted to PDQ		2000-08-03
Information Last Verified		2002-08-29
NCI Grant/Contract Number		CA70019

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