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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
First received: September 11, 2000
Last updated: February 1, 2016
Last verified: February 2016

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.

Condition Intervention Phase
Biological: aldesleukin
Drug: ganciclovir
Drug: zidovudine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AIDS Malignancy Consortium:

Study Start Date: July 2000
Study Completion Date: July 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 120 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,000/mm3
  • Platelet count at least 50,000/mm3


  • Bilirubin and SGOT no greater than 3 times upper limit of normal
  • No major hepatic dysfunction as evidenced by encephalopathy, ascites, or varices


  • Creatinine clearance at least 60 mL/min


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Concurrent corticosteroids allowed


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006264

United States, Florida
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
Study Chair: William J. Harrington, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00006264     History of Changes
Other Study ID Numbers: AMC-019  CDR0000068204 
Study First Received: September 11, 2000
Last Updated: February 1, 2016
Health Authority: United States: Federal Government

Keywords provided by AIDS Malignancy Consortium:
AIDS-related primary CNS lymphoma

Additional relevant MeSH terms:
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Ganciclovir triphosphate
Analgesics, Non-Narcotic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Sensory System Agents

ClinicalTrials.gov processed this record on May 25, 2016