Trials / Completed
CompletedNCT00002621
Interferon Alfa in Treating Children With HIV-Related Cancer
A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | recombinant interferon alfa |
Timeline
- Start date
- 1994-12-01
- Primary completion
- 2002-07-01
- Completion
- 2005-09-01
- First posted
- 2003-08-11
- Last updated
- 2014-07-24
Locations
10 sites across 4 countries: United States, Canada, Puerto Rico, Switzerland
Source: ClinicalTrials.gov record NCT00002621. Inclusion in this directory is not an endorsement.