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

NCT00003114 | Completed Phase 2 DMC

• 5 other identifiers: CWRU2496P30CA043703CWRU-2496AMC-4A-90NCI-G97-1351
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

AIDS-related lymphoma; HIV-associated Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  The course is repeated every 6 weeks. Patients will be followed every 3 months until death.

Interventions

filgrastim BIOLOGICAL

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.

cyclophosphamide DRUG

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.

etoposide DRUG

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.

lomustine DRUG

Patients receive oral lomustine on day 1.

procarbazine hydrochloride DRUG

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.

radiation therapy RADIATION

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, AIDS-Related

Interventions

Filgrastim; Cyclophosphamide; Etoposide; Lomustine; Procarbazine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Therapeutics

Study Officials

• Scot C. Remick, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 13, 2003
• Study Start: July 1, 1997
• Primary Completion: June 1, 2002
• Study Completion: February 1, 2003
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)