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A Phase II Trial Of Induction Therapy With Zidovudine, Interleukin-2, And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

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 UniversityColumbus, Ohio  43210
Sylvester Cancer Center, University of MiamiMiami, Florida  33136