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

NCT00003114 — Phase 2, Completed, 5 participants, Case Comprehensive Cancer Center

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

RegistryNCT00003114
StatusCompleted
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment5 (Actual)
SponsorCase Comprehensive Cancer Center (Other); collaborators: National Cancer Institute (NCI)
ConditionsLymphoma
Interventionsfilgrastim, cyclophosphamide, etoposide, lomustine, procarbazine hydrochloride, radiation therapy (Biological, drug, radiation)
Datesstart 1997-07-01, primary completion 2002-06-01, completion 2003-02-01, first posted 2003-08-13, last updated 2010-06-11
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Lymphoma All trials of filgrastim All trials of cyclophosphamide

-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.

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+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.

+Arms and interventions

  • filgrastim (Biological): 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.
  • cyclophosphamide (Drug): 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 (Drug): 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 (Drug): Patients receive oral lomustine on day 1.
  • procarbazine hydrochloride (Drug): 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 therapy (Radiation): Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.

+Outcome measures

Primary outcomes

  • 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.]

+Eligibility

Sex: All

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

+Locations (1)

FacilityCityCountryStatus
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, OhioUnited States

+Investigators

  • Scot C. Remick, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

+Funding

NIH grants: P30CA043703