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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006264
• Other study ID #: AMC-019
• Secondary ID: CDR0000068204
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: February 1, 2016
• Start date: July 2000
• Est. completion date: July 2003

Study information

• Verified date: February 2016
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• aldesleukin

Drug:
• ganciclovir

• zidovudine

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Sylvester Cancer Center, University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. C — View Citation