Interferon Alfa in Treating Children With HIV-Related Cancer

July 23, 2014 updated by: Children's Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • McGill University Health Center - Montreal Children's Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico School of Medicine Medical Sciences Campus
  • Switzerland
      • Geneva, Switzerland, 1211
        • Clinique de Pediatrie
  • United States
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Tomorrows Children's Institute
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Saint Joseph's Health System
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Lackland Air Force Base, Texas, United States, 78236-5300
        • San Antonio Military Pediatric Cancer and Blood Disorders Center
      • San Antonio, Texas, United States, 78284-7811
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response rate for HIV related malignancies treated with interferon
Time Frame: Length of study
Length of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Event Free Survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: V. M. Whitehead, MD, Montreal Children's Hospital at McGill University Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1994

Primary Completion (Actual)

July 1, 2002

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 8, 2003

First Posted (Estimate)

August 11, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9362 (CTEP)
  • POG-9362 (Other Identifier: Pediatric Oncology Group)
  • CDR0000063972 (Other Identifier: Clinical Trials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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