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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2023 |
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Main ID: |
NCT00846430 |
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Date of registration:
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16/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Medical Treatment of "High-Risk" Neurofibromas
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Scientific title:
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Medical Treatment of "High-Risk" Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical Therapies |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00846430 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Albert S Cornelius, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helen DeVos Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- "High-Risk" Plexiform Neurofibromas associated with a diagnosis of NF1
- 2-30 years old (minimum bodyweight of 10 kilograms)
- Adequate renal function
Exclusion Criteria:
- Previously untreated active optic glioma
- History of any previous allergy to study medications
- History of ischemic vascular disease
- Pregnancy / Breast feeding
Age minimum:
2 Years
Age maximum:
30 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neurofibromatosis 1
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Intervention(s)
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Drug: Celecoxib (Celebrex)
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Drug: Temozolomide (temodar)
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Drug: Peg-Interferon alpha-2b
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Drug: Vincristine Sulfate (Oncovin)
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Primary Outcome(s)
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Tumor response based on evaluation of symptom assessment, tumor measurements, and MRI studies - Toxicity of treatment combinations based upon laboratory studies and physical examination
[Time Frame: Monthly physical exam first three months and then every three months after, MRI's will occur at baseline, 6, 12 and 24 months.]
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Secondary Outcome(s)
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Psychological toxicity based upon psychological evaluations - Improved quality of life based upon physical examination and performance scales
[Time Frame: Psychological evaluation at baseline, 3, 12, and 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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