Treatment of Cutaneous Metastases With Diphenylcyclopropenone (DPCP)

November 27, 2017 updated by: Patricia Gilleaudeau, Rockefeller University

An Open Label Study Employing the Topical Immunomodulator Diphenylcyclopropenone in a Stabilized Gel to Treat Cutaneous Metastases

Melanoma is a life-threatening cancer which poses a significant health burden, especially when metastatic or spreading to areas other than the original tumor growth. Although various treatment options are currently available for melanoma, melanomas that have metastasized widely to the skin pose a significant clinical challenge as the available therapies have limited effect. This study proposes the use of a topically applied compound named diphenylcyclopropenone (DPCP) which has been shown to be effective in treating melanoma patients whose diseases have spread widely throughout the skin. DPCP works by having a patient's own immune system, which is usually used to fight infections, attack cancerous cells. This compound has commonly been used to treat other conditions such as warts and hair loss throughout the world for many years and is known to cause limited side effects. Altering a patient's own immune system through topical treatments has also been shown to benefit patients with other cancers that have metastasized to skin such as breast cancer. In this study, the investigators will use DPCP to treat cutaneous metastases of various cancers including melanoma. Our overall intention is to get a better understanding of effective immune responses in the skin that may mediate metastatic cancer regression or cure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open label study to determine the efficacy and mechanism(s) of the proprietary DPCP gel composition as a topical immunotherapeutic agent for the treatment of cutaneous metastases. This study is investigator initiated, carried out only at Rockefeller University and the Sponsor holds the IND and is providing the test agent. The products to be evaluated are 0.4% DPCP, in a non-volatile gel vehicle, and 0.04% DPCP in the same gel vehicle applied to the target lesions biweekly for 14 weeks. It is our goal to apply the study drug to all cutaneous metastatic lesions, but at the Investigator's discretion, certain lesions will be avoided if they are in particularly difficult locations such as around the eyes or on the lips. The estimated duration of the study is 142 days with 112 days of treatment followed by subject examination on Day 142. If DPCP is shown to cause resolution of lesions by this visit, there will be the possibility of continuing DPCP use as long as study medication continues to be provided to The Rockefeller University.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • The Rockefeller University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female at least 18 years of age, up to 99 years of age
  • able to give verbal and written informed consent
  • clinically diagnosed cancer with multiple cutaneous metastases that are able to be biopsied. The subject may or may not be on concomitant cancer treatments/have internal metastases.
  • for women of childbearing potential (WOCBP) or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study (while receiving study medication and for one month following the last dose of study medication). Acceptable forms of contraception are listed in the informed consent form.
  • must have a negative urine pregnancy test (for WOCBP)
  • must be willing and able to have the therapy applied by the investigator, must be willing and able to self-apply the therapy, and must be willing and able to comply with study instructions and return for required clinic visits.
  • clinically diagnosed melanoma with multiple cutaneous metastasis that are able to be biopsied. The subject will be on concurrent PD-1 checkpoint inhibitor therapy (standard nivolumab or pembrolizumab, not on another clinical trial) and may or may not have internal metastasis.

Exclusion Criteria:

  • subjects taking any of the following systemic or topical therapies within 4 weeks of enrollment: corticosteroids, immunosuppressants, and/or any other medications that may affect the outcome of the study
  • subjects who have active localized or systemic medical conditions that, in the opinion of the investigator, would preclude or make unsafe their participation in the study
  • subjects with any underlying diseases or dermatological conditions of the affected areas that require the use of interfering topical or systemic therapy
  • subjects who are nursing mothers, pregnant, or planning to become pregnant at anytime during the course of the study or within 30 days of study completion
  • subjects who are unable to comply with study procedures, communicate effectively, cooperate with the investigator, or are unable to understand the study
  • history, physical, social, or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, make the candidate ineligible for the study
  • HIV positive as determined by self-reported history and/or a HIV point-of-care test at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Diphenylcyclopropenone (DPCP)
Subjects will have DPCP in a topical gel formulation applied to their cutaneous metastatic lesions.
Drug: Diphenylcyclopropenone (DPCP)
Topical application of study drug
Other Names:
  • DCP
  • Diphencyprone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
clinically evident inflammatory response elicited by DPCP and the clinically evident efficacy of DPCP to treat cutaneous metastases
Time Frame: Day 142
Day 142

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
histological and gene expression profiling of biopsy specimens
Time Frame: Day 142
Day 142

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rockefeller University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Krueger, MD, The Rockefeller University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JKR-0788

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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