Status:
COMPLETED
Topical Imiquimod 5% Cream for Treatment of Cutaneous Neurofibromas in Adults With Neurofibromatosis 1
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Neurofibromatosis Type 1
Cutaneous Neurofibromas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if imiquimod cream can reverse the growth of neurofibromas. Imiquimod is a skin cream that works by stimulating the body's immune system to respond to tumors....
Detailed Description
* Three of the participant's tumors will be treated with imiquimod cream and one tumor (out of all the remaining tumors) will be followed without treatment (control tumor). * Participants will be give...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of NF1 based on NIH criterial with two or more of the following characteristics:
- six or more cafe-au-lait macules (1.5cm or greater in size)
- skin fold freckling in the axilla or groin
- optic pathway glioma
- two or more Lisch nodules of the iris
- distinctive bony lesions such as dysplasia of the sphenoid wing or of a long bone such as the tibia
- two or more neurofibromas of any type of 1 or more plexiform neurofibroma
- first degree relative with NF1
- Participants must have at least four cutaneous neurofibromas on skin exam with the following qualities:
- the lesion must be discrete by clinical exam and must not be contact with another skin tumor
- the lesion must be amenable to measurement with calipers with minimum dimension of 5mm and maximum dimension of 30mm
- the lesions must be located on the trunk, neck, or extremities (excluding the hands and feet) and must be located in an area that can be photographed
- histologic confirmation of tumor type is not required in the setting of compatible clinical setting
- No treatment with an investigation agent for cutaneous neurofibromas within the last 3 months
- 18 years of age or older
Exclusion
- Pregnant and nursing women
- Patients who have had chemotherapy or radiotherapy within 6 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 6 weeks earlier
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to imiquimod
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00865644
Start Date
March 1 2009
End Date
December 1 2013
Last Update
January 10 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114