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

Phase 1
18 Years
Open (Enrolling)
Neoplasm Metastasis, Melanoma

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Trial Information

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

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.

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.

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

- 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

- HIV positive as determined by self-reported history and/or a HIV point-of-care test
at screening

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinically evident inflammatory response elicited by DPCP

Outcome Time Frame:

Day 142

Safety Issue:


Principal Investigator

James Krueger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Rockefeller University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

October 2017

Related Keywords:

  • Neoplasm Metastasis
  • Melanoma
  • Neoplasm Metastasis
  • Melanoma
  • Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Skin Neoplasms



The Rockefeller University New York, New York  10065