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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00563290 |
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with unresectable or metastatic squamous cell skin cancer.
Condition | Intervention | Phase |
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Non-Melanomatous Skin Cancer |
Drug: dasatinib Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Dasatinib in Patients With Transplant and Non-Transplant Related Unresectable or Metastatic Cutaneous Squamous Cell Carcinoma |
Estimated Enrollment: | 35 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to squamous cell carcinoma of the skin origin (transplantation vs nontransplantation).
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Pre-therapy tumor biopsy specimens are collected to detect total and phosphorylated Src and FAK, total EphA2, and cyclooxygenase-2 by immunohistochemistry.
After completion of study treatment, patients are followed monthly for up to 12 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the skin
Brain metastases are allowed provided the following are true:
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease including the following:
No uncontrolled intercurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior radiotherapy
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Study Chair: | Thomas E. Olencki, DO | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Miguel A. Villalona-Calero ) |
Study ID Numbers: | CDR0000576527, OSU-07070 |
Study First Received: | November 22, 2007 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00563290 History of Changes |
Health Authority: | Unspecified |
squamous cell carcinoma of the skin recurrent skin cancer |
Skin Diseases Dasatinib Epidermoid Carcinoma Neoplasms, Squamous Cell Squamous Cell Carcinoma Skin Neoplasms |
Carcinoma, Squamous Cell Protein Kinase Inhibitors Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Skin Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Skin Neoplasms Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Dasatinib Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |