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Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease
This study is ongoing, but not recruiting participants.
Study NCT00003114   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
July 1997
 
 
 
Complete list of historical versions of study NCT00003114 on ClinicalTrials.gov Archive Site
 
 
 
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.

Phase II
Interventional
Treatment
Lymphoma
  • Biological: filgrastim
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: lomustine
  • Drug: procarbazine hydrochloride
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
16
 
 

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
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003114
 
CDR0000065864, CWRU-2496, AMC-4A-90, NCI-G97-1351
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Scot C. Remick, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
September 2002

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