Interferon Alfa in Treating Children With HIV-Related Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002621
Recruitment Status : Completed
First Posted : August 11, 2003
Last Update Posted : July 24, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific Biological: recombinant interferon alfa Phase 2

Detailed Description:


  • 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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Alpha interferon (aIFN) treatment
See detailed description.
Biological: recombinant interferon alfa
Other Names:
  • Intron A
  • Roferon A
  • NSC 377523

Primary Outcome Measures :
  1. Complete response rate for HIV related malignancies treated with interferon [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Event Free Survival [ Time Frame: 1 year ]

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven malignancy diagnosed at any time following confirmation of HIV-positivity, including the following:

    • Leukemia
    • Non-Hodgkin's lymphoma
    • CNS lymphoma
    • Other solid tumors
  • Measurable disease
  • Concurrent registration on protocol POG-9182 required

    • Confirmed HIV-positive by POG-9182 criteria
    • Required biology studies completed



  • 21 and under

Performance status:

  • Not specified

Life expectancy:

  • More than 4 weeks


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3 (unless bone marrow involvement present)


  • See Disease Characteristics
  • Bilirubin less than 1.5 times normal
  • SGPT and SGOT less than 2 times normal (may discuss with Study Coordinator)


  • Creatinine less than 1.5 mg/dL


  • Adequate cardiac function by echocardiogram/MUGA scan


  • Chronically infected patients must be stable enough to meet life expectancy requirement


Biologic therapy:

  • No prior interferon for cancer
  • Prior interferon alfa for viral infections (i.e., hepatitis) must be discussed with Study Coordinator


  • At least 1 week since prior chemotherapy

Endocrine therapy:

  • Not specified


  • At least 1 week since prior radiotherapy


  • Not specified


  • Prior antiretroviral therapy allowed
  • At least 1 week since prior acute treatment for any serious or life-threatening infection
  • No concurrent local treatment unless discussed with the Study Coordinator
  • No concurrent acute treatment for any serious or life-threatening infection
  • Concurrent antiretroviral therapy allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its 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
Canada, Quebec
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Clinique de Pediatrie
Geneva, Switzerland, 1211
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: V. M. Whitehead, MD Montreal Children's Hospital at McGill University Health Center

Responsible Party: Children's Oncology Group Identifier: NCT00002621     History of Changes
Other Study ID Numbers: 9362
POG-9362 ( Other Identifier: Pediatric Oncology Group )
CDR0000063972 ( Other Identifier: Clinical )
First Posted: August 11, 2003    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Children's Oncology Group:
recurrent childhood acute lymphoblastic leukemia
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
unspecified childhood solid tumor, protocol specific
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
stage I childhood small noncleaved cell lymphoma
stage I childhood large cell lymphoma
stage II childhood small noncleaved cell lymphoma
stage II childhood large cell lymphoma
stage III childhood small noncleaved cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood small noncleaved cell lymphoma
stage IV childhood large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs