THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on nonmelanoma skin cancers—basal cell carcinoma; merkel cell carcinoma; cutaneous lymphoma; and squamous cell carcinoma. These studies are investigating brachytherapy; topical treatments; novel chemotherapeutic agents; antibiotics; immunotherapy; and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Johns Hopkins University
Purpose: To determine if topically applied itraconazole, an antifungal medication which may affect the hedgehog signaling pathway, affects the growth of basal cell carcinomas
Primary Outcome Measures: Downregulation in glucagon-like immunoreactivity expression [time frame: day 8]
Principal Investigator: Nikki Tang, MD, Johns Hopkins University; (410) 502-7546, ctrep@jhmi.edu
ClinicalTrials.gov Identifier: NCT02120677
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Study Title: Phase I, Single-Arm, Open-Label, Dose Escalation Trial of MNA-Doxorubicin in Patients-Subjects With Cutaneous T-Cell Lymphoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Pittsburgh
Purpose: To test a new method of experimental treatment for CTCL using small adhesive-like patches (a micro-needle applicator), which have dozens of microneedles loaded with extremely low doses of doxorubicin
Primary Outcome Measures: Evaluate the safety of the micro array needle doxorubicin system confirmed by vital signs, hematology, comprehensive metabolic panel, assessment for skin toxicity, and adverse event evaluation [time frame: 9 weeks]
Principal Investigator: Oleg E. Akilov, MD, PhD, University of Pittsburgh; (412) 864-3681, akilovoe@upmc.edu
ClinicalTrials.gov Identifier: NCT02192021
PHASE I/II
Study Title: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma With Cutaneous Presentation: A Biomarker Phase Ib/IIa Study
Study Type: Interventional/nonrandomized/sequential assignment
Study Sponsor and Collaborators: Columbia University
Purpose: To investigate AFM13 and evaluate its ability to facilitate and redirect natural killer (NK) cells in eliminating CD30-positive lymphoma targets in the skin and, by inference, other organs involved by lymphoma
Primary Outcome Measures: Percentage of intratumoral NK-cells and T-cells infiltration into tumors; number of immune cells in tumor and peripheral blood; level of plasma cytokine production plus release in tumor and peripheral blood as a function of treatment [time frame: up to 2 years]
Principal Investigator: Ahmed Sawas, MD, Columbia University Medical Center; contact Celeste Rojas, (212) 326-5720, lymphoma@cumc.columbia.edu
ClinicalTrials.gov Identifier: NCT03192202
PHASE II
Study Title: A Phase II Study of Talimogene Laherparepvec Followed by Talimogene Laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the effectiveness of talimogene laherparepvec and nivolumab in treating patients with lymphomas or nonmelanoma skin cancers
Primary Outcome Measures: Best overall response rate to talimogene laherparepvec alone as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [time frame: up to 1 year]
Principal Investigator: Ann Silk, MD, Rutgers University Cancer Institute of New Jersey; visit clinicaltrials.gov for various location contacts
ClinicalTrials.gov Identifier: NCT02978625
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Study Title: Doxycycline in Patients With Relapsed Cutaneous T-Cell Lymphoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Rochester General Hospital
Purpose: To study the efficacy of doxycycline, an antibiotic, for the treatment of cutaneous T-cell lymphomas
Primary Outcome Measures: Efficacy of doxycycline in relapsed cutaneous T-cell lymphoma [time frame: from baseline to 5 months or 1 year, depending on response]
Principal Investigator: Brian Poligone, MD, PhD, Rochester General Hospital; (585) 364-1188
ClinicalTrials.gov Identifier: NCT02341209
PHASE III
Study Title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase III Trial of Adjuvant Avelumab in Merkel Cell Carcinoma Patients With Clinically Detected Lymph Node Metastases
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: University of Washington, National Cancer Institute
Purpose: To study how well avelumab works in treating patients with Merkel cell cancer that has spread to the lymph nodes and have undergone surgery with or without radiation therapy
Primary Outcome Measures: Relapse-free survival [time frame: from date of randomization and the date of first recurrence or death (whatever the cause), whichever occurs first, assessed for up to 5 years]
Principal Investigator: Shailender Bhatia, MD, Fred Hutch/ University of Washington Cancer Consortium; contact Nichole Pelz, (206) 606-7476, adamtrial@seattlecca.org
ClinicalTrials.gov Identifier: NCT03271372
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. ■
