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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: cyclophosphamide; Biological: filgrastim; Drug: lomustine; Drug: procarbazine hydrochloride; Drug: etoposide; Radiation: radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003114

NCI-G97-1351

CWRU2496

P30CA043703 (U.S. NIH Grant/Contract)

AMC-4A-90

CWRU-2496 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)