Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, acral melanoma, mucosal melanoma, vulvovaginal melanoma, stage III melanoma
Eligibility Criteria
Inclusion Criteria for Pre-Registration (Step 0):
Histologically or cytologically confirmed melanoma of 1 of the following subtypes:
- Acral melanoma (defined as occurring on the palms, soles, or subungual sites)
- Melanoma arising from the vagina and/or vulva
- Melanoma arising on other mucosal surface (not vagina or vulva)
- Unresectable locally advanced or metastatic disease
c-KIT mutation identified by polymerase chain reaction (PCR) and sequencing meeting 1 of the following criteria:
- At least 1 mutation in exon 9, 11, 13, 17, or 18
- At least 1 mutation in an exon not listed above and approved by central reviewer
- Metastatic tumor blocks are required for the evaluation of KIT mutations or amplifications
- Prior radiotherapy to a measurable lesion allowed provided there is radiographic evidence of progression of that lesion
- No other concurrent malignancies except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or other malignancies from which the patient has been continuously disease-free for ≥ 5 years
- ECOG performance status 0-1
Exclusion Criteria for Pre-Registration (Step 0):
- Prior treatment with targeted therapies directed to c-KIT/PDGFR (e.g., imatinib or sunitinib)
- Ocular melanoma
- Evidence of bleeding diathesis
- Clinically significant psychiatric illness or social situations that would limit compliance with study requirements
Clinically significant cardiovascular disease including the following:
- Myocardial infarction or ventricular tachyarrhythmia within 6 months
- Prolonged QTc >480 msec (Fridericia correction)
- Ejection fraction less than institutional normal
- Major conduction abnormality (unless a cardiac pacemaker is present)
- Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) are to be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation
- Patients with underlying cardiopulmonary dysfunction are excluded from the study
Inclusion Criteria for Registration (Step 1):
- Meeting the eligibility criteria for pre-registration (Step 0)
- The melanoma must harbor a c-KIT mutation determined by PCR and sequencing as defined in the protocol either by local assessment or Massachusetts General Hospital (MGH)
- Measurable disease, defined as at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- At least 4 weeks since prior chemotherapy, radiotherapy or immunotherapy and the beginning of protocol therapy and the patient must have recovered from toxicity due to the previous therapy
History or clinical evidence of brain metastasis allowed provided the following criteria are met:
- Completed radiotherapy or surgical treatment of brain lesions and there is no evidence of central nervous system (CNS) progression for ≥ 8 weeks
- Must not require corticosteroids for treatment of cerebral edema from brain metastases
- Negative pregnancy test
- Fertile patients must use effective contraception
Patients must have the following within 4 weeks of registration:
- computed tomography (CT) chest with intravenous (IV) and oral agent
- CT pelvis/abdomen with IV and oral agent
- MRI brain with gadolinium
- Baseline bone scan required for patients with known bone metastases, elevated alkaline phosphatase, or symptoms raising suspicion of bone metastases
- White blood count (WBC) ≥ 3,000/mm³
- Absolute granulocyte count (AGC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 40 mL/min
- Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert disease)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)
- Serum potassium and magnesium normal (repletion allowed)
- Total serum calcium or ionized calcium ≥ institutional lower limit of normal
International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) wtihin normal limits
- Therapeutic anticoagulation with warfarin allowed provided INR ≤ 1.5 or PTT normal prior to initiating anticoagulation therapy
Exclusion Criteria for Registration (Step 1):
- Pregnant or nursing
- Concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (i.e., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John wort)
Uncontrolled hypertension, defined as systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg
- Hypertension that is adequately controlled with medication allowed
- QTc prolongation, defined as a QTc interval ≥ 450 msecs
- Serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Stanford Cancer Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Baptist Cancer Institute - Jacksonville
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Winship Cancer Institute of Emory University
- Kapiolani Medical Center at Pali Momi
- Oncare Hawaii, Incorporated - Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- Kuakini Medical Center
- OnCare Hawaii, Incorporated - Kuakini
- Kapiolani Medical Center for Women and Children
- Castle Medical Center
- Kauai Medical Clinic
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Elmhurst Memorial Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Indiana University Melvin and Bren Simon Cancer Center
- Veterans Affairs Medical Center - Indianapolis
- William N. Wishard Memorial Hospital
- McFarland Clinic, PC
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - McPherson
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Saint Luke's Hospital - South
- Cancer Center of Kansas, PA - Parsons
- CCOP - Kansas City
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Greater Baltimore Medical Center Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts General Hospital
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Green Bay Oncology, Limited - Escanaba
- Dickinson County Healthcare System
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- New Ulm Medical Center
- Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- North Kansas City Hospital
- Heartland Hematology Oncology Associates, Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Parvin Radiation Oncology
- Heartland Regional Medical Center
- Saint Joseph Oncology, Incorporated
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Case Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- St. Rita's Medical Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Bryn Mawr Hospital
- Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
- Lewistown Hospital
- Cancer Center of Paoli Memorial Hospital
- Abramson Cancer Center of the University of Pennsylvania
- UPMC Cancer Centers
- Mount Nittany Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- UW Cancer Center Johnson Creek
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Marshfield Clinic - Lakeland Center
- D.N. Greenwald Center
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Green Bay Oncology, Limited - Oconto Falls
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- St. Nicholas Hospital
- Marshfield Clinic at Saint Michael's Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- Waukesha Memorial Hospital Regional Cancer Center
- Marshfield Clinic - Wausau Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
Arms of the Study
Arm 1
Experimental
Dasatinib
Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.