Clinical trial NCT00003114: Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease
Official title: Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: AIDS-related lymphoma
HIV-associated Hodgkin lymphoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-13
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
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.
timeFrame: The course is repeated every 6 weeks. Patients will be followed every 3 months until death.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Scot C. Remick, MD
role: STUDY_CHAIR
References: