A PHASE II STUDY OF ALPHA INTERFERON (ALPHA INTERFERON) IN HIV-RELATED MALIGNANCIES
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.
Interventional
Primary Purpose: Treatment
V. M. Whitehead, MD
Study Chair
Montreal Children's Hospital at McGill University Health Center
United States: Federal Government
CDR0000063972
NCT00002621
December 1994
Name | Location |
---|---|
Tomorrows Children's Institute | Hackensack, New Jersey 07601 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Mission Saint Joseph's Health System | Asheville, North Carolina 28801 |