This trial is active, not recruiting.

Conditions mucosal lentiginous melanoma, acral melanoma, melanoma
Treatment nilotinib
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator Brigham and Women's Hospital
Start date January 2009
End date October 2011
Trial size 20 participants
Trial identifier NCT00788775, 08-244, DUS11T


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
nilotinib Tasigna
400mg by mouth twice a day

Primary Outcomes

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

Secondary Outcomes

To determine early evidence of biologic and clinical activity in melanoma patients treated with nilotinib by best overall response rate.
time frame: 3 years
To estimate time to progression of disease and overall survival in this patient population
time frame: 3 years
To determine the tolerability of nilotinib in this patient population.
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study of Nilotinib (AMN107) In TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma
Principal investigator F. Stephen Hodi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.