Melanoma Clinical Trial
Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery
Summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.
Full Description
OBJECTIVES:
Primary
To estimate the objective tumor response rate in patients with KIT-positive, unresectable, locally advanced or metastatic acral or mucosal melanoma treated with dasatinib monotherapy.
Secondary
To estimate the response duration in patients treated with this drug.
To estimate the progression-free survival of patients treated with this drug.
To evaluate the safety profile of this drug in these patients.
To evaluate the PDGFR expression and activation of Src family kinases in tumor samples and correlate these parameters with response to treatment.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tissue samples may be collected from some patients for correlative studies.
After completion of study therapy, patients are followed up periodically for up to 5 years.
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
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There are 131 Locations for this study
Little Rock Arkansas, 72205, United States
Stanford California, 94305, United States
Fort Lauderdale Florida, 33308, United States
Jacksonville Florida, 32207, United States
Jupiter Florida, 33458, United States
Miami Beach Florida, 33140, United States
Orlando Florida, 32803, United States
Atlanta Georgia, 30322, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Kailua Hawaii, 96734, United States
Lihue Hawaii, 96766, United States
Chicago Illinois, 60611, United States
Elmhurst Illinois, 60126, United States
Maywood Illinois, 60153, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Ames Iowa, 50010, United States
Bettendorf Iowa, 52722, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51102, United States
Sioux City Iowa, 51104, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
McPherson Kansas, 67460, United States
Newton Kansas, 67114, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66213, United States
Parsons Kansas, 67357, United States
Prairie Village Kansas, 66208, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Escanaba Michigan, 49431, United States
Iron Mountain Michigan, 49801, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64118, United States
Kansas City Missouri, 64132, United States
Lee's Summit Missouri, 64086, United States
Liberty Missouri, 64068, United States
Saint Joseph Missouri, 64506, United States
Saint Joseph Missouri, 64507, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Lima Ohio, 45801, United States
Tulsa Oklahoma, 74136, United States
Bryn Mawr Pennsylvania, 19010, United States
Hershey Pennsylvania, 17033, United States
Lewistown Pennsylvania, 17044, United States
Paoli Pennsylvania, 19301, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
State College Pennsylvania, 16803, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Chippewa Falls Wisconsin, 54729, United States
Eau Claire Wisconsin, 54701, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Johnson Creek Wisconsin, 53038, United States
Madison Wisconsin, 53792, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Minocqua Wisconsin, 54548, United States
Mukwonago Wisconsin, 53149, United States
Oconomowoc Wisconsin, 53066, United States
Oconto Falls Wisconsin, 54154, United States
Rhinelander Wisconsin, 54501, United States
Rice Lake Wisconsin, 54868, United States
Sheboygan Wisconsin, 53081, United States
Stevens Point Wisconsin, 54481, United States
Sturgeon Bay Wisconsin, 54235, United States
Waukesha Wisconsin, 53188, United States
Wausau Wisconsin, 54401, United States
Weston Wisconsin, 54476, United States
Wisconsin Rapids Wisconsin, 54494, United States
Casper Wyoming, 82609, United States
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