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

NCT ID: NCT00006264

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2003-07-31

Brief Summary

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.

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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

ganciclovir

Intervention Type: DRUG

zidovudine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

AIDS Malignancy Consortium

NETWORK

Sponsor Role: lead

Principal Investigators

William J. Harrington, MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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. doi: 10.3816/clm.2006.n.017.

Reference Type: RESULT

PMID: 16640817 (View on PubMed)

Other Identifiers

CDR0000068204

Identifier Type: OTHER

Identifier Source: secondary_id

AMC-019

Identifier Type: -

Identifier Source: org_study_id