Clinical Trials Directory

Trials / Completed

CompletedNCT00253474

PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma

A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
National Institutes of Health Clinical Center (CC) · NIH
Sex
All
Age
1 Year – 21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPEG-interferon alfa-2a

Timeline

Start date
2005-09-01
Completion
2011-01-01
First posted
2005-11-15
Last updated
2012-03-29

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00253474. Inclusion in this directory is not an endorsement.