Clinical Trial: Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Trial of Adjuvant Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy

Brief Summary: The study is designed to determine the 32 month rate of distant relapse in patients with uveal melanoma who are at high risk of recurrence following definitive therapy with surgery or radiation who receive adjuvant crizotinib; and secondarily, the overall survival and disease specific survival in this patient population.

Detailed Summary:

Uveal melanoma is the most common primary intraocular malignancy in adults, and arises from melanocytes within the choroid plexus of the eye. Melanomas of the ocular and adnexal structures comprise approximately 5% of all melanomas and are biologically and prognostically distinct from cutaneous melanoma. In the United States, an estimated 2000 patients are diagnosed with this disease each year.

The development of metastasis in this disease is common and occurs in approximately 50% of patients with posterior uveal melanoma within 15 years after the initial diagnosis and treatment. Uveal melanoma is thought to be particularly resistant to systemic treatment, and no systemic therapy has yet been demonstrated to improve survival. Drugs commonly used to treat advanced cutaneous melanoma rarely achieve durable responses in patients with uveal melanoma.


Sponsor: Columbia University

Current Primary Outcome: Relapse Free Survival (RFS) rate [ Time Frame: Up to 36 months ]

RFS rate will be defined as the percentage of patients who do not experience any new tumor growth at any site on the body distant from the primary site or death from any cause from the time of study entry to the end of the relevant timepoint.


Original Primary Outcome: Relapse free survival (RFS) [ Time Frame: 3 years ]

RFS rate will be defined as the percentage of patients who do not experience any new tumor growth at any site on the body distant from the primary site or death from any cause from the time of study entry to the end of the relevant timepoint.


Current Secondary Outcome:

  • Overall Survival (OS) rate [ Time Frame: Up to 36 months ]
    OS will be defined as the time from treatment start to date of death or last followup and estimated using Kaplan-Meier methodology.
  • Disease-Specific Survival (DSS) time [ Time Frame: Up to 36 months ]
    DSS is defined as the time from treatment start to death due to disease or last followup.
  • Prevalence of treatment discontinuation due to toxicity [ Time Frame: 48 weeks ]
    Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.


Original Secondary Outcome:

  • Overall survival (OS) [ Time Frame: 3 years ]
    Overall survival (OS) will be defined as the time from treatment start to date of death or last followup and estimated using Kaplan-Meier methodology.
  • Disease-specific survival (DSS) [ Time Frame: 3 years ]
    Disease-specific survival (DSS) is defined as the time from treatment start to death due to disease or last followup.
  • Toxicity [ Time Frame: 3 years ]
    Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.


Information By: Columbia University

Dates:
Date Received: August 20, 2014
Date Started: March 2015
Date Completion: August 2019
Last Updated: December 15, 2016
Last Verified: December 2016