Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Novartis
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00788775
First received: November 10, 2008
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The purpose of this research study is to evaluate how effective nilotinib is in treating acral, mucosal, or melanoma arising from sun damaged skin which has spread and was not found to respond to treatment with another Tyrosine Kinase Inhibitor (including but not limited to imatinib mesylate, sunitinib or dasatinib treatment)or was not tolerated.


Condition Intervention Phase
Mucosal Lentiginous Melanoma
Acral Melanoma
Melanoma
Drug: Nilotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Nilotinib (AMN107) In TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To estimate the proportion of this patient population who are alive and without disease progression four months after beginning treatment with nilotinib. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine early evidence of biologic and clinical activity in melanoma patients treated with nilotinib by best overall response rate. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To estimate time to progression of disease and overall survival in this patient population [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine the tolerability of nilotinib in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: January 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
400mg by mouth twice a day

Detailed Description:
  • Participants will be given nilotinib pills. Each pill contains 200 mg of nilotinib and participants will take two pills twice a day.
  • Participants will have a physical exam weekly for the first month and then about every other month. At every visit blood work will be performed. An EKG will be done prior to the first dose of study medication and within 30 minutes after the first dose and also on day 8 of month 1, 3, 6, and 9. An echocardiogram will be performed during the 3rd month.
  • After a month of receiving the study drug participants will undergo a PET scan to see if the drug has caused any detectable early changes in their cancer. A chest, abdomen and pelvic CT scan will be performed at the end of month 2 and about every 8 weeks after that to assess if the study drug is having any effect on the disease.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Histologically documented diagnosis of mucosal melanoma or acral melanoma or chronically sun damaged melanoma as evidenced by solar elastosis on pathology
  • Patient's tumor with evidence for KIT mutation or amplification. Patient tumors that already have documented mutations or amplification do not have to have tissue submitted again for analysis to confirm eligibility
  • Have failed, progressed, or not been able to tolerate other tyrosine kinase inhibitors including but not limited to imatinib mesylate, sunitinib or dasatinib treatment.
  • At least one measurable site of disease
  • ECOG Performance Status 0, 1 or 2
  • Adequate organ function as outlined in the protocol
  • Negative pregnancy test for female patients of childbearing potential

Exclusion Criteria:

  • Patient has received any other investigational agents within 28 days of first day of study drug dosing unless the disease is rapidly progressing
  • Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ
  • Female patients who are pregnant or breast-feeding
  • Patient has a severe and/or uncontrolled medical disease
  • Patient has a rare hereditary problem of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption
  • Patient with electrolyte abnormality unless the level can be corrected to normal levels prior to initiating study drug
  • Known brain metastasis
  • Known chronic liver disease
  • Patient has received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing (6 weeks for nitrosourea or mitomycin-C)
  • Patient previously received radiotherapy to 25% or greater of the bone marrow
  • Patient had a major surgery within 2 weeks prior to study entry
  • Impaired cardiac function
  • QTc > 450msec on screening ECG
  • Myocardial infarction within one year prior to starting nilotinib
  • Other clinically significant heart disease
  • Patients who are currently receiving treatment with any of the medications that have the potential to prolong QT interval
  • Patients who are currently receiving Warfarin > 1mg/day
  • Patient with any significant history of non-compliance to medical regimens or with the inability to grant reliable informed consent
  • Prior therapy with nilotinib
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788775

Locations
United States, California
The Angeles Clinic and Research Institute
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Novartis
Investigators
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: F. Stephen Hodi, MD, Melanoma Disease Center Director, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00788775     History of Changes
Other Study ID Numbers: 08-244, DUS11T
Study First Received: November 10, 2008
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
nilotinib

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014