View Clinical Trial (Medical Research Study)
Medical Treatment of "High-Risk" Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical Therapies
| City: |
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Grand Rapids |
| State: |
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Michigan |
| Zip Code: |
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49503 |
| Conditions: |
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Neurofibromatosis 1 |
| Purpose: |
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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.
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| Study Summary: |
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The study's design involves treating eligible patients with a combination of celecoxib and
pegylated interferon alpha-2b. If the patients have at least a partial response after six
months, they may continue on the same treatment for up to two years. If the patient
experiences less than a partial response, or has progressive disease after six months of
therapy, then vincristine and temozolomide will be added to the celecoxib and interferon
alpha-2b backbone. Response to treatment will be assessed after a minimum of six months,
presuming the patient has not experienced progressive disease. Total duration of therapy on
study is two years for any individual treatment plan.
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| 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
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| NCT ID: |
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NCT00846430 |
| Primary Contact: |
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Principal Investigator
Albert S Cornelius, MD
Helen DeVos Children's Hospital
Sara Finton, RN
Phone: 616-391-9365
Email: sara.finton@spectrum-health.org
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| Backup Contact: |
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Email: heidi.smith@spectrum-health.org
Heidi Smith, RN
Phone: 616-391-9364
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| Location Contact: |
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Grand Rapids, Michigan 49503
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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