Interferon Alfa in Treating Children With HIV-Related Cancer
NCT ID: NCT00002621
Last Updated: 2014-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
1994-12-31
2005-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alpha interferon (aIFN) treatment
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recombinant interferon alfa
Interventions
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recombinant interferon alfa
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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V. M. Whitehead, MD
Role: STUDY_CHAIR
Montreal Children's Hospital at McGill University Health Center
Locations
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Via Christi Regional Medical Center
Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tomorrows Children's Institute
Hackensack, New Jersey, United States
Mission Saint Joseph's Health System
Asheville, North Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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Other Identifiers
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POG-9362
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000063972
Identifier Type: OTHER
Identifier Source: secondary_id
9362
Identifier Type: -
Identifier Source: org_study_id
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