Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02839720
Phase
PHASE2
Status
Completed

Conditions

  • Cutaneous Neurofibroma
  • Neurofibromatosis Type 1
  • Optic Nerve Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This pilot phase II trial studies how well selumetinib works in treating patients with neurofibromatosis type 1 and cutaneous neurofibromas. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Aug 26, 2017
Status verified
Dec 2023
Primary completion
Nov 5, 2022
Completion
Aug 31, 2023

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (selumetinib sulfate)
    Patients receive selumetinib sulfate PO twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience a volume decrease in the target cutaneous neurofibromas may continue treatment for 12 additional cycles.

Primary Outcome Measure

Median Best Response of Cutaneous Neurofibromas in Participants With at Least One Restaging Evaluation [ Time Frame: Up to 24 cycles of treatment (1 cycle = 28 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALNational Institutes of Health Clinical Center· Bethesda, MD

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