This study is designed to establish the foundation for a new therapy for neurofibromatosis Type I (NF1)-related cutaneous neurofibromas (cNFs) by assessing the feasibility and efficacy of IMLYGIC in adults with NF1 and cNFs who desire local treatment of their cNF due to disfigurement, progression, pain, itching or other concerns. This is a single institutional Phase 1 study with a safety run-in to assess the feasibility and efficacy of IMLYGIC monotherapy in NF1 patients with cNFs. Each 28-day treatment cycle will be defined as intralesional administration of IMLYGIC administered on day 1 and 21 of Cycle 1 and days 7 and 21 for Cycles 2-4 for up to 4 cycles.
Males or females age ≥ 18 years who meet the NIH clinical criteria for the diagnosis of NF1
Singular lesion surrounded by uninvolved skin measuring ≥ 5 mm in the longest diameter but not larger than 5 cm
Not covered by hair
There is no skin breakdown in the tumor or the skin around it
Any underlying medical condition, which in the opinion of the investigator, would make administration of the study drug hazardous or make it difficult to monitor adverse effects.
Known HIV infection or AIDS
Acute or chronic active hepatitis B or hepatitis C infection
Chronic oral or systemic steroid medication use at a dose of >10 mg/day of prednisone or equivalent (steroids with low systemic absorption [e.g., triamcinolone hexacetonide] is allowed)
Single group
Imlygic
Drugintralesional administration of IMLYGIC administered on Days 1 and 21 of each cycle for 4 cycles (8 treatments).
Feasibility of IMLYGIC as assessed by percentage of participants receiving 4 treatments
Feasibility is defined as ≥80% of participants receiving 4 treatments
Tolerability of IMLYGIC as assessed by participants without Dose Limiting Toxicity (DLT) or Serious Adverse Event (SAE)
Tolerability is defined as no participants have a DLT or SAE
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Johns Hopkins University
Lead sponsor
Amgen
Collaborator
