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

This study is no longer recruiting patients.

Sponsors and Collaborators: AIDS Associated Malignancies Clinical Trials Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
AIDS-related primary CNS lymphoma
 Drug: ganciclovir
 Drug: interleukin-2
 Drug: zidovudine
 Procedure: antiviral therapy
 Procedure: biological response modifier therapy
 Procedure: cytokine therapy
 Procedure: interleukin therapy
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Zidovudine, Interleukin-2, and Ganciclovir in Patients With Primary AIDS Related Central Nervous System Lymphoma

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Location Information


Florida
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States

Study chairs or principal investigators

William J. Harrington, MD,  Study Chair,  Sylvester Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068204; AMC-019
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006264
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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