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Interferon Alfa in Treating Children With HIV-Related Cancer

Primary Purpose

Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
recombinant interferon alfa
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Via Christi Regional Medical Center
  • MBCCOP - LSU Health Sciences Center
  • Tomorrows Children's Institute
  • Mission Saint Joseph's Health System
  • Medical City Dallas Hospital
  • San Antonio Military Pediatric Cancer and Blood Disorders Center
  • University of Texas Health Science Center at San Antonio
  • McGill University Health Center - Montreal Children's Hospital
  • University of Puerto Rico School of Medicine Medical Sciences Campus
  • Clinique de Pediatrie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alpha interferon (aIFN) treatment

Arm Description

See detailed description.

Outcomes

Primary Outcome Measures

Complete response rate for HIV related malignancies treated with interferon

Secondary Outcome Measures

Event Free Survival

Full Information

First Posted
November 1, 1999
Last Updated
July 23, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002621
Brief Title
Interferon Alfa in Treating Children With HIV-Related Cancer
Official Title
A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 1994 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alpha interferon (aIFN) treatment
Arm Type
Experimental
Arm Description
See detailed description.
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Other Intervention Name(s)
Intron A, Roferon A, NSC 377523
Primary Outcome Measure Information:
Title
Complete response rate for HIV related malignancies treated with interferon
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
Event Free Survival
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. M. Whitehead, MD
Organizational Affiliation
Montreal Children's Hospital at McGill University Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tomorrows Children's Institute
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Mission Saint Joseph's Health System
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
San Antonio Military Pediatric Cancer and Blood Disorders Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236-5300
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
Facility Name
McGill University Health Center - Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
University of Puerto Rico School of Medicine Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Clinique de Pediatrie
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

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Interferon Alfa in Treating Children With HIV-Related Cancer

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