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.

Condition	Treatment or Intervention	Phase
HIV-associated Hodgkin's disease AIDS-Related Lymphoma	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: radiation therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Drug: cyclophosphamide  Drug: etoposide  Drug: filgrastim  Drug: lomustine  Drug: procarbazine	Phase II

Further Study 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.

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)

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

Study chairs or principal investigators

Scot C. Remick,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000065864; CWRU-2496; NCI-G97-1351; AMC-4A-90
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003114
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08