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Medical Treatment of "High-Risk" Neurofibromas

NCT00846430 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-08-30

Study results available
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Summary

Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in severe pain, physical disability, organ dysfunction and/or become life-threatening. Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform neurofibromas, and surgery does not provide lasting help. This study will evaluate the effectiveness of two treatment combinations in patients with "high-risk" plexiform neurofibromas.

Conditions

  • Neurofibromatosis 1

Interventions

DRUG

Peg-Interferon alpha-2b

age and weight dependant

DRUG

Celecoxib (Celebrex)

age and weight dependant

DRUG

Temozolomide (temodar)

age and weight dependant

DRUG

Vincristine Sulfate (Oncovin)

age and weight dependant

Sponsors & Collaborators

  • Spectrum Health Hospitals

    lead OTHER

Principal Investigators

  • Albert S Cornelius, MD · Helen DeVos Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2017-04-30
Completion
2017-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846430 on ClinicalTrials.gov