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Phase II Pilot Study of Epirubicin/Bleomycin/Vinblastine/Prednisone with G-CSF and Either Zidovudine or Didanosine in HIV-Associated Hodgkin's Disease (Summary Last Modified 01/98)
Basic Trial Information
Objectives I. Evaluate the remission rate, toxicity, disease-free survival, and overall survival associated with epirubicin/bleomycin/vinblastine/prednisone in patients with HIV-associated Hodgkin's disease. II. Determine whether infectious complications can be decreased in these patients by using either zidovudine or didanosine in combination with chemotherapy. III. Determine whether the use of granulocyte colony-stimulating factor can reduce or eliminate chemotherapy treatment delays. Entry Criteria Disease Characteristics: Histologically proven Hodgkin's disease in association with AIDS Clinical or pathologic stage II/III/IV disease or stage I disease with adverse prognostic factors, i.e.: Bulky disease (tumor mass larger than 10 cm) B symptoms Presence of HIV antibodies determined by ELISA and confirmed by Western blot Prior/Concurrent Therapy: No prior therapy Patient Characteristics: Age: Over 15 Performance status: WHO 0-3 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No severe cardiac, pulmonary, neurologic, or metabolic disease that decreases normal life expectancy or contraindicates therapy No prior or concurrent malignancy except: Nonmelanomatous skin cancer In situ cervical carcinoma Expected Enrollment It is anticipated that 30-40 patients will be entered. Outline All patients receive intravenous epirubicin, bleomycin, and vinblastine on day 1 and oral prednisone on days 1-5. Subcutaneous G-CSF is given on days 6-20. Treatment repeats every 3 weeks for a total of 6 courses. Antiretroviral therapy with zidovudine or didanosine is given twice daily concomitantly with chemotherapy regardless of the CD4 cell count. Patients are followed every 2 months for 1 year, then every 3 months. Trial Lead Organizations Centro di Riferimento Oncologico - Aviano
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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