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.

Condition	Treatment or Intervention	Phase
Leukemia Lymphoma	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: interferon therapy  Procedure: cytokine therapy  Drug: cytarabine  Drug: hydrocortisone  Drug: interferon alfa	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa. II. Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients.

PROTOCOL 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.

Ages Eligible for Study:  up to  21 Years

Criteria

PROTOCOL ENTRY 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 AND
• Required biology studies completed

--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

--Patient Characteristics--

Age: 21 and under

Performance status: Not specified

Life expectancy: More than 4 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm3
• Platelet count at least 100,000/mm3 (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

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

Study chairs or principal investigators

V. Michael Whitehead,  Study Chair,  Pediatric Oncology Group   

Study ID Numbers:  CDR0000063972; POG-9362
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002621
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08