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Treatment of Cutaneous Metastases With Diphenylcyclopropenone (DPCP)

Primary Purpose

Neoplasm Metastasis, Melanoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Diphenylcyclopropenone (DPCP)

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Neoplasm Metastasis, Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Rockefeller University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diphenylcyclopropenone (DPCP)

Arm Description

Subjects will have DPCP in a topical gel formulation applied to their cutaneous metastatic lesions.

Outcomes

Primary Outcome Measures

clinically evident inflammatory response elicited by DPCP and the clinically evident efficacy of DPCP to treat cutaneous metastases

Secondary Outcome Measures

histological and gene expression profiling of biopsy specimens

Full Information

NCT ID

NCT01711684

First Posted

October 18, 2012

Last Updated

November 27, 2017

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT01711684

Brief Title

Treatment of Cutaneous Metastases With Diphenylcyclopropenone (DPCP)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 16, 2012 (Actual)

Primary Completion Date

June 22, 2015 (Actual)

Study Completion Date

June 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rockefeller University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm Metastasis, Melanoma

Keywords

Neoplasm Metastasis, Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diphenylcyclopropenone (DPCP)

Arm Type

Experimental

Arm Description

Subjects will have DPCP in a topical gel formulation applied to their cutaneous metastatic lesions.

Intervention Type

Drug

Intervention Name(s)

Diphenylcyclopropenone (DPCP)

Other Intervention Name(s)

Diphencyprone, DCP

Intervention Description

Topical application of study drug

Primary Outcome Measure Information:

Title

clinically evident inflammatory response elicited by DPCP and the clinically evident efficacy of DPCP to treat cutaneous metastases

Time Frame

Day 142

Secondary Outcome Measure Information:

Title

histological and gene expression profiling of biopsy specimens

Time Frame

Day 142

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Krueger, MD

Organizational Affiliation

The Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Cutaneous Metastases With Diphenylcyclopropenone (DPCP)

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