Spots Global Cancer Trial Database for Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver
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Trial Identification
Brief Title: Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver
Official Title: An Open Label, Expanded Access Study of Melphalan Chemosaturation With the Delcath System in Patients With Ocular and Cutaneous Melanoma Metastatic to the Liver
Study ID: NCT01728051
Study Description
Brief Summary: The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted in the same patient population as well as using the same melphalan dosing as proposed in this study. This expanded access protocol will provide an experimental alternative treatment option for both physicians and patients until the Delcath CS-PHP System receives marketing approval.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, California, United States
Sky Ridge Medical Center, Englewood, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey, United States
University of Pittsburg Cancer Institute, Pittsburgh, Pennsylvania, United States
Contact Details
Name: Charles W Nutting, DO
Affiliation: Sky Ridge Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jonathan Zager, MD
Affiliation: H. Lee Moffitt Cancer Center and Research Institue at University of Southern Florida
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Faries, MD
Affiliation: Saint John's Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: James F Pingpank, MD
Affiliation: Univeristy of Pittsburg Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Eric D Whitman, MD
Affiliation: Carol G. Simon Cancer Center at Morristown Memorial Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: H. Richard Alexander, MD
Affiliation: University of Maryland Medical Center
Role: PRINCIPAL_INVESTIGATOR
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