Interferon Alfa in Treating Children With HIV-Related Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific
Intervention: cytarabine (Drug); recombinant interferon alfa (Drug); therapeutic hydrocortisone (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Pediatric Oncology Group Official(s) and/or principal investigator(s):
V. M. Whitehead, MD, Study Chair, Affiliation: Montreal Children's Hospital at McGill University Health Center
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.
Clinical Details
Official title: A PHASE II STUDY OF ALPHA INTERFERON (ALPHA INTERFERON) IN HIV-RELATED MALIGNANCIES
Study design: Treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
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
Locations and Contacts
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan 00936-5067, Puerto Rico
Clinique de Pediatrie, Geneva 1211, Switzerland
Via Christi Regional Medical Center, Wichita, Kansas 67214, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States
Tomorrows Children's Institute, Hackensack, New Jersey 07601, United States
Mission Saint Joseph's Health System, Asheville, North Carolina 28801, United States
McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec H3H 1P3, Canada
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
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1994
Last updated: May 23, 2008
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