Advertisement

Clinical Trials Actively Recruiting Patients With Basal Cell Carcinoma


The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on basal cell carcinoma. These studies are investigating laser treatment; topical ointments; photodynamic therapy; Hedgehog signaling pathway targeting agents; shave removal; and surgical margins. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

Study Title: Long-Pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma (BCC)

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: University of California, San Diego; Massachusetts General Hospital

Purpose: To evaluate the safety and efficacy of laser treatment of subjects with BCC on the trunk and extremities. Subjects will receive one treatment with the laser to the BCC. Standard excision will be performed between 30 and 90 days after laser treatment to evaluate resolution of the BCC.

Primary Outcome Measures: Efficacy of the Nd:YAG laser to cause complete regression of BCC [time frame: the primary outcome of the study is histologic clearance of BCC tumor 30 to 90 days]

Principal Investigator: Arisa Ortiz, MD, University of California, San Diego; (858) 657-1697, ucsddermstudies@gmail.com

ClinicalTrials.gov Identifier: NCT02662244

***

Study Title: A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of BCC

Study Type: Pilot/interventional/single-group assignment

Study Sponsor and Collaborators: Johns Hopkins University

Purpose: To study the molecular effects of topically applied itraconazole ointment on the growth of BCCs

Primary Outcome Measures: Downregulation in Gli expression [time frame: day 8]

Principal Investigator: Timothy S. Wang, MD, Johns Hopkins University; (410) 502-7546, ctrep@jhmi.edu

ClinicalTrials.gov Identifier: NCT02120677

***

Study Title: Pilot Trial Comparing Two Different Wavelengths of Light (Blue Vs Red) During Levulan-Based Photodynamic Therapy of BCC in Patients With Basal Cell Nevus ­Syndrome

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute

Purpose: To study how well photodynamic therapy using blue light or red light works in treating BCC in patients with a genetic condition that causes unusual facial features and disorders of the skin, bones, nervous system, eyes, and endocrine glands (also called basal cell nevus syndrome)

Primary Outcome Measures: Tumor diameter; mean reduction in tumor diameter; mean reduction in number of tumors; number of lesions with complete response; number of lesions with partial response; number of lesions with no response; average time to clearance for lesions with a complete response; percent of lesions with a complete response [time frame: up to 6 months]; time to recurrence following complete response [time frame: up to 2 years]; protoporphyrin IX levels in tumors [time frame: up to 6 months posttreatment]

Principal Investigator: Edward Maytin, MD, PhD, Case Comprehensive Cancer Center; (216) 445-6676; maytine@ccf.org

ClinicalTrials.gov Identifier: NCT02258243

***

Study Title: Vismodegib for Orbital and Periocular BCC

Study Type: Phase IV/interventional/single-group assignment

Study Sponsor and Collaborators: University of Michigan Cancer Center

Purpose: To assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCC.

Primary Outcome Measures: The number of patients with a score of 21 or greater by the Visual Assessment Weighted Score (VAWS) at 1 year [time frame: 1 year]

Principal Investigator: Alon ­Kahana, MD, PhD, University of Michigan; (734) 936-8654, akahana@med.umich.edu

ClinicalTrials.gov Identifier: NCT02436408

***

Study Title: An Observational Study to Determine the Clinical Cure Rate of Therapeutic Upfront Shave Removal of BCC of the Skin With Long-Term Follow-up to Evaluate ­Recurrence

Study Type: Observational

Study Sponsor and Collaborators: University of Pittsburgh

Purpose: To determine the effectiveness of a deep shave removal as a definitive treatment for BCC without the need for a follow-up surgical ­procedure

Primary Outcome Measures: Measurement of clinical cure rate of deep shave removal in the treatment of BCC [time frame: 6 months]

Principal Investigator: Timothy Patton, DO, University of Pittsburgh; (412) 681-1072, pattontj@upmc.edu

ClinicalTrials.gov Identifier: NCT02296970

***

Study Title: Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial BCCs

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: Thomas Jefferson University

Purpose: To study the effectiveness of narrow margins in patients with low-risk BCC undergoing surgery to remove skin lesions on the face by examining tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate.

Primary Outcome Measures: Success rate for 1-mm margins, success rate for 2-mm margins [time frame: up to 3 years]

Principal Investigator: Jason Lee, MD, Thomas Jefferson University; (215) 955-6680

ClinicalTrials.gov Identifier: NCT02579551

***

Study Title: Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: University of Miami

Purpose: To preliminarily assess the efficacy and safety of the 595/1064 nm Multiplex laser when treating superficial and nodular BCCs less than 1.5 cm in size

Primary Outcome Measures: Number of lesions cleared clinically and histologically [time frame: 91 days]

Principal Investigator: Keyvan Nouri, MD, University of Miami Sylvester Comprehensive Cancer Center; (305) 243-3380, knouri@med.miami.edu

ClinicalTrials.gov Identifier: NCT02270645 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.



Advertisement

Advertisement



Advertisement

click me