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Analysis of Immune Reactions Occurring in Normal Volunteers Upon Administration of the Topical Immunomodulator Diphenylcyclopropenone

18 Years
60 Years
Open (Enrolling)
Healthy Volunteers

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Trial Information

Analysis of Immune Reactions Occurring in Normal Volunteers Upon Administration of the Topical Immunomodulator Diphenylcyclopropenone

The immune system is the primary line of defense against infections and other things
perceived as foreign to the body. Unfortunately, this immune system often fails to
eliminate tumors or other cancerous growths. The drug diphenylcyclopropenone, or DPCP,
modifies the immune system and has been shown to be effective in treating certain kinds of
cancer. This study hopes to improve our understanding of how this drug helps create an
effective immune response. In order to reach this goal, normal volunteers will be given the
DPCP drug in the form of a gel or a placebo gel (gel without the active chemical) on a few
small areas of skin. Then, biopsies will be taken of the skin at the sites where the active
drug was placed. Also, small biopsies will be taken from opposite areas of skin which
received placebo gel to serve as controls. The biopsied skin samples will then be studied
by methods such as immunohistochemistry and microarray analysis which will help define the
immune reaction caused by DPCP. The rationale for the study is to better understand how the
immune system can be activated to produce cells that may fight infections or cancers.

Inclusion Criteria:

- Male or non-pregnant female between 18 and 60 years of age

- Able to give verbal and written informed consent

- 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 protocol.

- Must have a negative urine pregnancy test (for WOCBP)

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

- Known sensitivity to bandage or adhesive tape.

- 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 concomitant diagnosis that may influence immune
reactions (e.g. eczema, psoriasis, lupus)

- 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

- Subjects who have been treated with another investigational device or drug within 30
days of enrollment

- HIV positive as determined by self-reported history and/or a HIV POCT at screening

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

James Krueger, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rockefeller University


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Healthy Volunteers



The Rockefeller UniversityNew York, New York  10065