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Nilotinib in Imatinib(Gleevec) Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma
This study is not yet open for participant recruitment.
Verified by Dana-Farber Cancer Institute, November 2008
Sponsors and Collaborators: Dana-Farber Cancer Institute
Brigham and Women's Hospital
Novartis
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00788775
  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 prior treatment with Gleevec or that Gleevec was not tolerated.


Condition Intervention Phase
Mucosal Melanoma
Acral Melanoma
Melanoma
Drug: Nilotinib
Phase I

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Imatinib Imatinib mesylate 4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase II Study of Nilotinib (AMN107) In Imatinib Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma

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: 25
Study Start Date: November 2008
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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 imatinib mesylate (Gleevec) 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
  • QTcF > 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

Contacts
Contact: F. Stephen Hodi, MD 617-632-5053

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Novartis
Investigators
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Dana-Farber Cancer Institute ( F. Stephen Hodi, MD )
Study ID Numbers: 08-244, DUS11T
Study First Received: November 10, 2008
Last Updated: November 10, 2008
ClinicalTrials.gov Identifier: NCT00788775  
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
nilotinib

Study placed in the following topic categories:
Imatinib
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009