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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003114
• Other study ID #: CWRU2496
• Secondary ID: P30CA043703CWRU-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 9, 2010
• Start date: July 1997
• Est. completion date: February 2003

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2003
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

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.
• 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.
• lomustine
Patients receive oral lomustine on day 1.
• 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.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No