Interferon Alfa in Treating Children With HIV-Related Cancer
|ClinicalTrials.gov Identifier: NCT00002621|
Recruitment Status : Completed
First Posted : August 11, 2003
Last Update Posted : July 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific||Biological: recombinant interferon alfa||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study|
|Study Start Date :||December 1994|
|Actual Primary Completion Date :||July 2002|
|Actual Study Completion Date :||September 2005|
Experimental: Alpha interferon (aIFN) treatment
See detailed description.
Biological: recombinant interferon alfa
- Complete response rate for HIV related malignancies treated with interferon [ Time Frame: Length of study ]
- Event Free Survival [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002621
|United States, Kansas|
|Via Christi Regional Medical Center|
|Wichita, Kansas, United States, 67214|
|United States, Louisiana|
|MBCCOP - LSU Health Sciences Center|
|New Orleans, Louisiana, United States, 70112|
|United States, New Jersey|
|Tomorrows Children's Institute|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|Mission Saint Joseph's Health System|
|Asheville, North Carolina, United States, 28801|
|United States, Texas|
|Medical City Dallas Hospital|
|Dallas, Texas, United States, 75230|
|San Antonio Military Pediatric Cancer and Blood Disorders Center|
|Lackland Air Force Base, Texas, United States, 78236-5300|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|McGill University Health Center - Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H 1P3|
|University of Puerto Rico School of Medicine Medical Sciences Campus|
|San Juan, Puerto Rico, 00936-5067|
|Clinique de Pediatrie|
|Geneva, Switzerland, 1211|
|Study Chair:||V. M. Whitehead, MD||Montreal Children's Hospital at McGill University Health Center|