Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease
N/A
N/A
Both
Lymphoma
Trial Information
Oral Combination Chemotherapy in the Treatment of AIDS-Associated 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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
The course is repeated every 6 weeks. Patients will be followed every 3 months until death.
Safety Issue:
No
Principal Investigator
Scot C. Remick, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU2496
NCT ID:
NCT00003114
Start Date:
July 1997
Completion Date:
February 2003
Related Keywords:
- Lymphoma
- AIDS-related lymphoma
- HIV-associated Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
