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Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma Clinical research trials and Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma. Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "Z" Clinical Trials Conditions > Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma  Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
For Condition: AIDS-related primary CNS lymphoma
Status: No longer recruiting
Sponsor(s): AIDS Associated Malignancies Clinical Trials Consortium , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamHarrington, Study Chair, Sylvester Cancer Center
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Additional Information:
Study ID Numbers: CDR0000068204; AMC-019
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006264
Other Aids-Related Primary Cns Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
2. Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
3. Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
4. Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
Related Studies:
Other AIDS-related primary CNS lymphoma Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
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