An Open Label Study Employing the Topical Immunomodulator Diphenylcyclopropenone in a Stabilized Gel to Treat Cutaneous Metastases
Sponsored by Rockefeller University, 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.
For patients to be considered for this study, they must be male
or female at least 18 years of age, up to 99 years of age; able
to give verbal and written informed consent; and 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. Women must have a negative urine pregnancy
test (for WOCBP), and 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 include 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;
and HIV positive as determined by self-reported history and/
or a HIV point-of-care test at screening
Pilot Study to Evaluate the Anti-Tumor Effect of Erlotinib Administered Before Surgery in Operable Patients With Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Sponsored by Comprehensive Cancer Center of Wake Forest
University in collaboration with Comprehensive Cancer Center
of Wake Forest University, this clinical trial is studying how
well erlotinib hydrochloride works when given before surgery
in treating patients with head and neck cancer that can be removed
by surgery. Studying samples of tumor tissue from
patients with cancer in the laboratory may help doctors learn
more about changes that occur in DNA and identify biomarkers
related to cancer. The primary outcome is to estimate the
correlation of the change in each biomarker with level of response,
perform a series of 2-sample t-tests to determine which
biomarkers exhibited a significant difference between responders
and non-responders, the investigators will also examine
whether the baseline measures of individual biomarkers are
significantly predictive of subsequent response status. To do
this the investigators will assess the correlation of the baseline
biomarker and subsequent response outcome and perform
2-sample t-tests comparing the mean baseline biomarker values
between responders and non-responders.
To be included, patients must histologically or cytologically have
a confirmed diagnosis of Squamous Cell Carcinoma (SCC) of
the Head and Neck: maxillary sinuses, oral cavity, oropharynx,
