A Phase II Trial Of Induction Therapy With Zidovudine, Interleukin-2, And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Trial Of Induction Therapy With Zidovudine, Interleukin-2, And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
William J. Harrington, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068204
NCT ID:
NCT00006264
Start Date:
July 2000
Completion Date:
July 2003
Related Keywords:
- Lymphoma
- AIDS-related primary CNS lymphoma
- Lymphoma
Name | Location |
|---|---|
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
