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Immunotherapy

DPCP for Neurofibromatosis

Phase 1
Waitlist Available
Led By Nicholas Gulati, MD, PhD
Research Sponsored by Nicholas Gulati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
At least four cutaneous neurofibromas greater than 4 mm in size that are able to be biopsied
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 77 or 107
Awards & highlights

Study Summary

This trial is researching a new treatment for neurofibromatosis, which is a disorder that causes tumors to form on the nerves. The treatment is a topical medication that is applied to the skin once a week, and the trial will test the safety and effectiveness of the medication.

Who is the study for?
This trial is for adults over 18 with Neurofibromatosis type 1 (NF1) who have at least four cutaneous neurofibromas. Participants must not be pregnant, nursing, or taking certain medications like corticosteroids and immunosuppressants that could affect the study's outcome. They should also not have any immune-impairing conditions.Check my eligibility
What is being tested?
The trial tests DPCP, a topical immune system activator applied once weekly for ten weeks to treat cutaneous neurofibromas in NF1 patients. This Phase I study focuses on safety and tolerability as its primary goal, with tumor treatment effectiveness as a secondary aim.See study design
What are the potential side effects?
Potential side effects of DPCP may include local skin reactions such as redness, itching or swelling at the application site. Since it activates the immune system, there might also be risks of systemic allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have at least four skin growths larger than 4 mm that can be biopsied.
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I am a woman who could still become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 77 or 107
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 77 or 107 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects with a grade 3 adverse event
Symptom standardized assessment scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: DPCPExperimental Treatment1 Intervention
0.4% ointment

Find a Location

Who is running the clinical trial?

Nicholas GulatiLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
Nicholas Gulati, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
27 Total Patients Enrolled
Rebecca Brown, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Diphencyprone (DPCP) (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05438290 — Phase 1
Neurofibroma Research Study Groups: DPCP
Neurofibroma Clinical Trial 2023: Diphencyprone (DPCP) Highlights & Side Effects. Trial Name: NCT05438290 — Phase 1
Diphencyprone (DPCP) (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438290 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for enrollees in this research study?

"Affirmative. Clinicaltrials.gov confirms that this medical research, which was initially posted on September 1st 2022, is currently seeking participants. A total of 30 individuals are expected to register for the study at a single location."

Answered by AI

To what extent can DPCP be detrimental to patients?

"A score of 1 was given to DPCP's safety due its Phase 1 status, meaning there is minimal evidence validating efficacy and security."

Answered by AI

What is the enrollment cap for this clinical trial?

"Affirmative. The information on clinicaltrials.gov reveals that this research project, which was initially posted on September 1st 2022, is currently recruiting participants. Approximately 30 individuals will be sourced from one medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
DPCP to Treat Cutaneous Neurofibromas Associated With NF1
Nicholas Gulati 2022. "DPCP to Treat Cutaneous Neurofibromas Associated With NF1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438290.
All > Neurofibromatosis Type 1 > Neurofibromatosis
~7 spots leftby Apr 2025
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