Phase 0

Study Title: Use of Definity® Contrast Agent for Ultrasound of Intraocular Tumors

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: Emory University

Purpose: To determine if microbubbles may be used as a contrast agent to help image tumors in the eye. In this study, patients with ocular melanoma who are going to have their eye removed will have their eye imaged by ultrasound before and after intravenous injection of microbubbles. The pathology characteristics of the tumor in the removed eye will be compared with the images.

Primary Outcome Measures: Ultrasound-enhanced image of intraocular tumor [time frame: 2 years]

Principal Investigator: Hans E. Grossniklaus, MD, Emory University; (404) 778-4611 ext 4613, ophtheg@emory.edu

ClinicalTrials.gov Identifier: NCT01930968

……………………………………………………………………………………………………………………………………………………………………

Phase I

Study Title: Phase Ib Trial of AEB071, a PCK Inhibitor, in Combination With BYL719, a PI3Kα Inhibitor, in Patients With Metastatic Uveal Melanoma

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: Richard D. Carvajal, MD, and Columbia University

Purpose: To define the maximum tolerated dose for the combination of AEB071 and BYL719. Secondary objectives are to define the safety and tolerability of AEB071 and BYL719.

Primary Outcome Measures: Total maximum tolerated dose (in milligrams) of AEB071 in combination with BYL719 [time frame: 4 years (approximately)]

Principal Investigator: Richard D. Carvajal, MD, Columbia University/Herbert Irving Cancer Center; (646) 317-6330, rdc2150@cumc.columbia.edu

ClinicalTrials.gov Identifier: NCT02273219

……………………………………………………………………………………………………………………………………………………………………

Phase II

Study Title: Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: MD Anderson Cancer Center

Purpose: To use sentinel lymph node (SLN) mapping to find SLNs and biopsy them to detect metastatic disease

Primary Outcome Measures: Rate of SLN (sentinel lymph node) positivity + false-negative events [time frame: every 3 months for year 1, every 6 months for years 2–5]

Principal Investigator: Bita Esmaeli, MD, MD Anderson Cancer Center; 713-794-1247

ClinicalTrials.gov Identifier: NCT00832429

……………………………………………………………………………………………………………………………………………………………………

Study Title: A Phase II Study of Vorinostat (NSC 701852) in Metastatic Uveal Melanoma

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: National Cancer Institute, Memorial Sloan Kettering, Moffitt Cancer Center P2C, Institut Curie Paris

Purpose: To determine if vorinostat works in treating patients with metastatic uveal melanoma Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome Measures: Overall response rate in patients with GNAQ/GNA11 mutant uveal melanoma, defined as the rate of complete and partial responses [time frame: up to 3 years]

Principal Investigator: Richard D. Carvajal, MD, Columbia University/Herbert Irving Cancer Center; (646) 317-6330, rdc2150@cumc.columbia.edu

ClinicalTrials.gov Identifier: NCT01587352

……………………………………………………………………………………………………………………………………………………………………

Study Title: Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma

Study Type: Interventional/nonrandomized/parallel assignment

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital

Purpose: To evaluate the response rate of bilateral disease participants who have at least one eye with advanced intra-ocular retinoblastoma (stratum B) using upfront therapy with chemotherapy delivered directly to the eye. The main biology objective is to improve our understanding of the biology and tumorigenesis of retinoblastoma when biology specimens are available.

Primary Outcome Measures: Response rate (complete or partial response) [time frame: after two upfront courses of chemotherapy (approximately 2 months after patient ­enrollment)]

Principal Investigator: Rachel C. Brennan, MD, St. Jude Children’s Research Hospital; (866) 278-5833, referralinfo@stjude.org

ClinicalTrials.gov Identifier: NCT01783535

……………………………………………………………………………………………………………………………………………………………………

Study Title: A Randomized Two-Arm Phase II Study of Trametinib Alone and in Combination With GSK2141795 in Patients With Advanced Uveal Melanoma

Study Type: Interventional/randomized/parallel assignment

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study how well trametinib with or without Akt inhibitor GSK2141795 (GSK2141795) works in treating patients with metastatic uveal melanoma

Primary Outcome Measures: Time to progression, defined from the date of randomization to the date of documented progression or death per RECIST [time frame: time from randomization to the earlier date of objective disease progression, assessed up to 12 months]

Principal Investigator: Alexander Shoustari, MD, Memorial Sloan Kettering Cancer Center; (212) 639-7202, shoushta@mskcc.org

ClinicalTrials.gov Identifier: NCT01979523 ■

……………………………………………………………………………………………………………………………………………………………………

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.