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Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Oral Combination Chemotherapy in the Treatment of AIDS-Associated 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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU2496

NCT ID:

NCT00003114

Start Date:

July 1997

Completion Date:

February 2003

Related Keywords:

  • Lymphoma
  • AIDS-related lymphoma
  • HIV-associated Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065