Interferon Alfa in Treating Children With HIV-Related Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00002621
First received: November 1, 1999
Last updated: July 23, 2014
Last verified: July 2014

November 1, 1999
July 23, 2014
December 1994
July 2002   (final data collection date for primary outcome measure)
Complete response rate for HIV related malignancies treated with interferon [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002621 on ClinicalTrials.gov Archive Site
Event Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Interferon Alfa in Treating Children With HIV-Related Cancer
A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study

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.

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
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Biological: recombinant interferon alfa
Other Names:
  • Intron A
  • Roferon A
  • NSC 377523
Experimental: Alpha interferon (aIFN) treatment
See detailed description.
Intervention: Biological: recombinant interferon alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
September 2005
July 2002   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 21 and under

Performance status:

  • Not specified

Life expectancy:

  • More than 4 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine less than 1.5 mg/dL

Cardiovascular:

  • Adequate cardiac function by echocardiogram/MUGA scan

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • At least 1 week since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 1 week since prior radiotherapy

Surgery:

  • Not specified

Other:

  • 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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland,   United States,   Canada,   Puerto Rico
 
NCT00002621
9362, POG-9362, CDR0000063972
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: V. M. Whitehead, MD Montreal Children's Hospital at McGill University Health Center
Children's Oncology Group
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP