Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease
| Registry | NCT00003114 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 5 (Actual) |
| Sponsor | Case Comprehensive Cancer Center (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Lymphoma |
| Interventions | filgrastim, cyclophosphamide, etoposide, lomustine, procarbazine hydrochloride, radiation therapy (Biological, drug, radiation) |
| Dates | start 1997-07-01, primary completion 2002-06-01, completion 2003-02-01, first posted 2003-08-13, last updated 2010-06-11 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Lymphoma All trials of filgrastim All trials of cyclophosphamide
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.
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.
Sex: All
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
| Facility | City | Country | Status |
|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio | United States |
NIH grants: P30CA043703