NCT00002621

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Dec 1994

Longer than P75 for phase_2 leukemia

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 11, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

7.6 years

First QC Date

November 1, 1999

Last Update Submit

July 23, 2014

Conditions

LeukemiaLymphomaUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

recurrent childhood acute lymphoblastic leukemiastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiaunspecified childhood solid tumor, protocol specificuntreated childhood acute myeloid leukemia and other myeloid malignanciesuntreated childhood acute lymphoblastic leukemiachildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomastage I childhood small noncleaved cell lymphomastage I childhood large cell lymphomastage II childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete response rate for HIV related malignancies treated with interferon

    Length of study

Secondary Outcomes (1)

  • Event Free Survival

    1 year

Study Arms (1)

Alpha interferon (aIFN) treatment

EXPERIMENTAL

See detailed description.

Biological: recombinant interferon alfa

Interventions

recombinant interferon alfaBIOLOGICAL
Also known as: Intron A, Roferon A, NSC 377523
Alpha interferon (aIFN) treatment

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tomorrows Children's Institute

Hackensack, New Jersey, 07601, United States

Location

Mission Saint Joseph's Health System

Asheville, North Carolina, 28801, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

McGill University Health Center - Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Clinique de Pediatrie

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaDendritic Cell Sarcoma, Interdigitating

Interventions

Interferon-alphaIntronsInterferon alpha-2

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • V. M. Whitehead, MD

    Montreal Children's Hospital at McGill University Health Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2003

Study Start

December 1, 1994

Primary Completion

July 1, 2002

Study Completion

September 1, 2005

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

PR(1)US(7)CH(1)CA(1)