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

This study has been completed.

Sponsors and Collaborators: AIDS Associated Malignancies Clinical Trials Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006264
  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 Intervention Phase
Lymphoma
Drug: aldesleukin
Drug: ganciclovir
Drug: zidovudine
Phase II

MedlinePlus related topics:   AIDS    Cancer    Lymphoma   

Drug Information available for:   Zidovudine    Ganciclovir    Ganciclovir sodium    Aldesleukin    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 2000

Detailed 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations

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

Locations
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 Associated Malignancies Clinical Trials Consortium
National Cancer Institute (NCI)

Investigators
Study Chair:     William J. Harrington, MD     Sylvester Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068204, AMC-019
First Received:   September 11, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006264
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related primary CNS lymphoma  

Study placed in the following topic categories:
Lymphatic Diseases
Aldesleukin
Immunoproliferative Disorders
HIV Seropositivity
Interleukin-2
HIV Infections
Acquired Immunodeficiency Syndrome
Zidovudine
Ganciclovir
Lymphoproliferative Disorders
Lymphoma
Central nervous system lymphoma, primary

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Neoplasms
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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