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Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease



Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease

For Condition: AIDS-Related Lymphoma,HIV-associated Hodgkin's disease
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Assess the feasibility and toxic effects of CECP in this patient population. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ScotRemick,  Study Chair,  Ireland Cancer Center

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065864;  CWRU-2496,NCI-G97-1351,AMC-4A-90
Study Start Date: July 1997
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003114

Other Aids-Related Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection

2. Peripheral Stem Cell Transplantation Followed By Infusion of White Blood Cells in Treating Patients With AIDS-Related Lymphoma

3. Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease

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Other AIDS-Related Lymphoma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials

Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease

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