Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
This study has been completed.
Sponsor:
AIDS Malignancy Clinical Trials Consortium
Collaborator:
Information provided by:
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00006264
First received: September 11, 2000
Last updated: January 22, 2013
Last verified: January 2013
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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 |
Biological: aldesleukin Drug: ganciclovir Drug: zidovudine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
Resource links provided by NLM:
Further study details as provided by AIDS Malignancy Clinical Trials Consortium:
| Study Start Date: | July 2000 |
| Study Completion Date: | July 2003 |
| Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
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 Malignancy Clinical Trials Consortium
Investigators
| Study Chair: | William J. Harrington, MD | University of Miami Sylvester Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006264 History of Changes |
| Other Study ID Numbers: | CDR0000068204, AMC-019 |
| Study First Received: | September 11, 2000 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by AIDS Malignancy Clinical Trials Consortium:
|
AIDS-related primary CNS lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Ganciclovir Zidovudine Aldesleukin Interleukin-2 Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on February 26, 2013
