Interferon Alfa in Treating Children With HIV-Related Cancer
- Conditions
- Unspecified Childhood Solid Tumor, Protocol SpecificLymphomaLeukemia
- Interventions
- Biological: recombinant interferon alfa
- Registration Number
- NCT00002621
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other solid tumors.
- Detailed Description
OBJECTIVES:
* Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa.
* Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients.
OUTLINE:
* Induction: Patients receive interferon alfa subcutaneously (SC) daily on days 1-14. Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally (IT) combined with cytarabine IT on day 14.
* Maintenance: Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1. Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity. Patients who received IT therapy during induction receive the same IT therapy at 4, 8, and 12 weeks and then every 8 weeks thereafter.
Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol.
PROJECTED ACCRUAL: A total of 14-30 evaluable patients will be accrued for this study within 4.2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alpha interferon (aIFN) treatment recombinant interferon alfa See detailed description.
- Primary Outcome Measures
Name Time Method Complete response rate for HIV related malignancies treated with interferon Length of study
- Secondary Outcome Measures
Name Time Method Event Free Survival 1 year
Trial Locations
- Locations (10)
Mission Saint Joseph's Health System
🇺🇸Asheville, North Carolina, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Tomorrows Children's Institute
🇺🇸Hackensack, New Jersey, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Clinique de Pediatrie
🇨🇭Geneva, Switzerland
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States