Expired Study
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Cleveland, Ohio 44106


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients with stage IIB, stage III, or stage IV AIDS-related Hodgkin's disease.


Study summary:

OBJECTIVES: - Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease. - Assess the feasibility and toxic effects of CECP in this patient population. OUTLINE: Patients receive oral lomustine on day 1, oral etoposide on days 1-3, and oral cyclophosphamide and procarbazine on days 22-31. Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42. The course is repeated every 6 weeks. Patients with a complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy. Patients failing to respond after 1 course are removed from the study. Patients will be followed every 3 months until death. PROJECTED ACCRUAL: A minimum of 16 evaluable patients will be accrued.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven stage IIB-IV AIDS-related Hodgkin's disease - Patients with Hodgkin's disease as the only HIV-related condition must have a positive ELISA for HIV confirmed by Western Blot - Measurable or evaluable disease - No cytologic or radiologic evidence of CNS involvement PATIENT CHARACTERISTICS: Age: - Any age Performance status: - ECOG 0-3 Life expectancy: - At least 6 weeks Hematopoietic: - WBC at least 1,500/mm3 - Platelet count at least 50,000/mm3 Hepatic: - Bilirubin no greater than 3.0 mg/dL Renal: - Creatinine no greater than 3.0 mg/dL Other: - Active infection is allowed (provided prognosis is estimated to be at least 6 weeks) PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for Hodgkin's disease - At least 4 weeks since chemotherapy for Kaposi's sarcoma Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy for localized stage I or II disease that has progressed beyond initial radiation ports is allowed Surgery: - Not specified Other: - Concurrent AZT therapy is allowed


NCT ID:

NCT00003114


Primary Contact:

Study Chair
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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