PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
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|ClinicalTrials.gov Identifier: NCT00253474|
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : March 29, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm of Uncertain Malignant Potential Unspecified Childhood Solid Tumor, Protocol Specific||Biological: PEG-interferon alfa-2a||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Official Title:||A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||January 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253474
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Brigitte C. Widemann, MD||National Cancer Institute (NCI)|