PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
- Conditions
- Neoplasm of Uncertain Malignant PotentialUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00253474
- Brief Summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b in treating young patients with plexiform neurofibroma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual as of 2/2005.)
* Determine the toxicity profile of this drug in these patients.
Secondary
* Obtain, preliminary, information about the efficacy of this drug in these patients.
* Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in patients treated with this drug.
* Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.
OUTLINE: This is a dose-escalation, multicenter study. (Dose-escalation portion of the study closed to accrual as of 2/2005.)
Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 2 years in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PEG-interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's National Medical Center🇺🇸Washington, District of Columbia, United States