Status:
COMPLETED
Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1
Lead Sponsor:
Mayo Clinic
Conditions:
Neurofibromatosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The study is a phase II, open label trial of oral Pirfenidone in 24 adult patients with neurofibromatosis type 1. Pirfenidone is a new, broad-spectrum anti-fibrotic drug, with proven in vitro and in ...
Detailed Description
Specific aims of this study are: 1. To evaluate efficacy of Pirfenidone in NF1 patients with disfiguring or disabling plexiform neurofibroma (PN) and spinal neurofibromas (SN) 2. To determine the acu...
Eligibility Criteria
Inclusion
- Diagnosis of neurofibromatosis type I, based on clinical criteria (NIH Consensus Development Conference, 1988). Tumors will not be confirmed histologically, since the biopsy could cause a change in tumor growth and such interfere with effect of Pirfenidone treatment.
- Male or female patients
- Age 18 years old
- All patients should be mentally capable of signing the consent form or should have a legal guardian to provide consent
- Patients who are experiencing symptoms from neurofibromatous lesions and who refuse surgery or are not good surgical candidates, such as those with plexiform neurofibroma who are experiencing significant discomfort, disfigurement or nerve compression or
- Presence of multiple spinal neurofibromas in which the surgical removal would carry a major risk for spinal cord damage.
Exclusion
- Tumors for which surgical removal could lead to permanent (or long-term) relief of symptoms
- Patients with open skin lesions and patients for whom surgery is being contemplated or who had surgery less than 4 weeks from starting treatment
- Patients for whom biopsy is warranted for suspected malignancies
- Individuals younger than 18 years
- Pregnant and lactating women
- Inability to have MR imaging (e.g. claustrophobia, pacemaker or allergy to contrast dye, if administration is needed for neurofibroma imaging)
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00754780
Start Date
September 1 2000
Last Update
March 19 2012
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