Neurofibromatosis Type 1 Clinical Trial
Official title:
Pilot Study of Topical Imiquimod 5% Cream for Treatment of Cutaneous Neurofibromas in Adults With Neurofibromatosis 1
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. Imiquimod cream is approved for use in patients with various skin lesions, including actinic keratosis, superficial basal cell carcinoma, and external genital warts. Information from these studies, as well as previous laboratory studies, suggest that imiquimod cream may help shrink neurofibromas or keep them from growing.
- 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 given a tube of imiquimod cream and be asked to apply it to the
three tumors 5 times per week, for a full 6 weeks (Monday through Friday).
- Participants will be required to come to the hospital for examinations on Week 1, 2, 4
and 6 (+/- 3 calendar days) and after their last dose of imiquimod cream on Weeks 9, 12
and 18 (+/- 5 calendar days. The following tests and procedures will be performed: skin
test; vital signs and measurements and photographs of the tumors. Participants will be
asked to participate in an optional skin biopsy on Week 4 and research blood tests wil
lbe taken on Day 1.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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