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, orophar-