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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006264
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 3, 2016
National Cancer Institute (NCI)
Information provided by:
AIDS Malignancy Consortium

September 11, 2000
January 27, 2003
February 3, 2016
July 2000
March 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006264 on Archive Site
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Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
A Phase II Trial Of Induction Therapy With Zidovudine, Interleukin-2, And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Biological: aldesleukin
  • Drug: ganciclovir
  • Drug: zidovudine
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Aboulafia DM, Ratner L, Miles SA, Harrington WJ Jr; AIDS Associated Malignancies Clinical Trials Consortium. Antiviral and immunomodulatory treatment for AIDS-related primary central nervous system lymphoma: AIDS Malignancies Consortium pilot study 019. Clin Lymphoma Myeloma. 2006 Mar;6(5):399-402.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
July 2003
March 2003   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068204 ( Other Identifier: NCI )
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AIDS Malignancy Consortium
National Cancer Institute (NCI)
Study Chair: William J. Harrington, MD University of Miami Sylvester Comprehensive Cancer Center
AIDS Malignancy Consortium
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP