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Immunomodulator
Diphencyprone + Immunotherapy for Skin Cancer
Phase 1
Recruiting
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
Subject's oncologist plans as next standard of care treatment to use an FDA-approved PD-1 or PD-L1 ICI therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 98 or 128
Awards & highlights
Study Summary
This trial is testing a new way to treat cancer by combining two existing treatments. It will compare how well this new treatment works to the existing treatments, and also track any side effects.
Who is the study for?
Adults with skin cancer and at least three cutaneous (skin) metastases, who are planned to receive FDA-approved PD-1 or PD-L1 immune checkpoint inhibitors. They must be in a relatively stable condition (ECOG 0-2), able to consent, and use contraception. Excluded are those on certain other treatments like steroids, allergic to DPCP components, pregnant/nursing women, individuals with HIV or specific lymph node removals affecting the treatment area.Check my eligibility
What is being tested?
The study is testing the effect of a topical drug called Diphencyprone (DPCP) applied twice weekly for 12 weeks alongside standard immune checkpoint inhibitors. It aims to observe changes in gene expression in treated skin cancer metastases and document any adverse events from this combination therapy.See study design
What are the potential side effects?
Potential side effects include local skin reactions where DPCP is applied such as redness, itching or blistering. Systemic side effects may occur due to immune checkpoint inhibition which can range from flu-like symptoms to more serious conditions involving the lungs, liver, intestines, hormone glands or other organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My next treatment is an FDA-approved immune therapy.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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I have skin cancer spread to at least three places that can be biopsied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 98 or 128
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 98 or 128
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diphencyprone (DPCP)Experimental Treatment1 Intervention
0.4% and 0.04% ointment
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Who is running the clinical trial?
Nicholas GulatiLead Sponsor
1 Previous Clinical Trials
17 Total Patients Enrolled
Nicholas Gulati, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
17 Total Patients Enrolled
Philip Friedlander, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
5 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have skin conditions or diseases that could interfere with the treatment.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I agree to use birth control during and for 90 days after the study.My next treatment is an FDA-approved immune therapy.I am able to care for myself and perform daily activities.I am not on a combination of immune checkpoint inhibitors.I am 18 years old or older.I am not on medications like corticosteroids or immunosuppressants that could affect the study.You have had allergic reactions to substances similar to DPCP or any other ingredients in the DPCP ointment.I have skin cancer spread to at least three places that can be biopsied.
Research Study Groups:
This trial has the following groups:- Group 1: Diphencyprone (DPCP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining opportunities to join this experiment?
"Clinicaltrials.gov reveals that this particular clinical trial, first posted on the 1st of September 2022 and recently updated on the 28th of July 2022 is no longer open for enrolment. However, there are still 787 other medical trials searching for participants at present time."
Answered by AI
To what extent does Diphencyprone (DPCP) pose risk to participants?
"Due to the limited amount of data available for DPCP in regards to both safety and efficacy, our research team at Power rated it a 1 on the scale."
Answered by AI
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