Lymphoma
Conditions
Keywords
AIDS-related lymphoma, HIV-associated Hodgkin lymphoma
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALfilgrastim
Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42.The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
DRUGcyclophosphamide
Oral cyclophosphamide on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
DRUGetoposide
Oral etoposide on days 1-3. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
DRUGlomustine
Patients receive oral lomustine on day 1.
DRUGprocarbazine hydrochloride
Oral and procarbazine on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
RADIATIONradiation therapy
Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | The course is repeated every 6 weeks. Patients will be followed every 3 months until death. |
Countries
United States
Outcome results
None listed