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

Status: Recruiting
Phase: Phase 2
Diagnosis: Melanoma
NCT ID: NCT00700882 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-194

 

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.

 

Conducting Institutions:
Massachusetts General Hospital, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Donald Lawrence, MD, Massachusetts General Hospital

Site-responsible Investigators:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute
David McDermott, MD, Beth Israel Deaconess Medical Center

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed melanoma of 1 of the following subtypes: - Acral melanoma (defined as occurring on the palms, soles, or subungual sites) - Mucosal melanoma (defined as arising on surfaces of the body such as the mouth, sinuses, rectum, or vagina) - Cutaneous melanoma with chronic sun damage (defined as the presence of solar elastosis in the skin adjacent to the melanoma) - Primary tumor blocks are required to confirm the presence of solar elastosis - Unresectable locally advanced or metastatic disease - Metastatic tumor blocks are required for the evaluation of KIT mutations or amplifications - Measurable disease, defined as at least one measurable lesion by RECIST criteria - Prior radiotherapy to a measurable lesion allowed provided there is radiographic evidence of progression of that lesion - No ocular melanoma - Baseline bone scan required for patients with known bone metastases, elevated alkaline phosphatase, or symptoms raising suspicion of bone metastases - 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 CNS progression for ≥ 8 weeks - Must not require corticosteroids for treatment of cerebral edema from brain metastases PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - WBC ≥ 3,000/mm³ - Absolute granulocyte count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 40 mL/min - Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert's disease) - AST and 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 normal - INR ≤ 1.5 and PTT normal - Therapeutic anticoagulation with warfarin allowed provided INR ≤ 1.5 or PTT normal prior to initiating anticoagulation therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No evidence of bleeding diathesis - No other 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 - No clinically significant cardiovascular disease (i.e., myocardial infarction or unstable angina), New York Heart Association class II-IV congestive heart failure, ventricular arrhythmia requiring medication, or peripheral vascular disease ≥ grade 2 within the past year - No 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 - No QTc prolongation, defined as a QTc interval ≥ 450 msecs - No concurrent serious illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics - No psychiatric illness or social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - No prior treatment with targeted therapies directed to C-KIT/PDGFR (e.g., imatinib mesylate or sunitinib malate) - Prior limb perfusion allowed - Prior systemic therapy allowed - At least 4 weeks since prior chemotherapy or immunotherapy - Prior adjuvant or neoadjuvant chemotherapy or immunotherapy allowed - At least 4 weeks since prior radiotherapy - No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (i.e., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
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