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

NCT ID: NCT00003114

Last Updated: 2010-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-07-31
• Study Completion Date: 2003-02-28

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

filgrastim

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.

Intervention Type: BIOLOGICAL

cyclophosphamide

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.

Intervention Type: DRUG

etoposide

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.

Intervention Type: DRUG

lomustine

Patients receive oral lomustine on day 1.

Intervention Type: DRUG

procarbazine 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.

Intervention Type: DRUG

radiation therapy

Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.

Intervention Type: RADIATION

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Scot C. Remick, MD

Role: STUDY_CHAIR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CWRU-2496

Identifier Type: OTHER

Identifier Source: secondary_id

AMC-4A-90

Identifier Type: -

Identifier Source: secondary_id

NCI-G97-1351

Identifier Type: -

Identifier Source: secondary_id

CWRU2496

Identifier Type: -

Identifier Source: org_study_id