Interferon Alfa in Treating Children With HIV-Related Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study

Conditions
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Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: recombinant interferon alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha interferon (aIFN) treatment<br>See detailed description. | Biological: recombinant interferon alfa<br> <br> * Other names: NSC 377523;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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