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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003114
First received: November 1, 1999
Last updated: June 9, 2010
Last verified: June 2010

November 1, 1999
June 9, 2010
July 1997
June 2002   (final data collection date for primary 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. [ Time Frame: The course is repeated every 6 weeks. Patients will be followed every 3 months until death. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00003114 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease
Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: 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.
  • Drug: 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.
  • 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.
  • Drug: lomustine
    Patients receive oral lomustine on day 1.
  • 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.
  • Radiation: radiation therapy
    Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
February 2003
June 2002   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003114
CWRU2496, P30CA043703, CWRU-2496, AMC-4A-90, NCI-G97-1351
Yes
Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Scot C. Remick, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP