su011248 in patients with metastatic mucosal or acral/lentiginous melanoma

Conditions: Mucosal Lentiginous Melanoma; Acral Lentiginous Malignant Melanoma

Summary: the purpose of this study is to evaluate how effective sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. it is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.

objectives: primary * to determine the proportion of participants with metastatic mucosal or acral/lentiginous melanoma who are alive and without disease progression at two months after beginning treatment with sunitinib. * to determine the best overall response rate. secondary * to determine the time to progression and overall survival. * to correlate c-kit mutational status with response to therapy. * to evaluate the use of fdg-pet scanning in determining early biologic response to therapy. * to assess amplification of c-kit status through quantitative pcr and/or fish and other related molecular pathway targets.

Eligibility criteria:
inclusion criteria: * history of primary mucosal or acral/lentiginous melanoma * histologically documented stage iii unresectable or iv metastatic melanoma * ecog performance status 0,1 or 2 * estimated life expectancy of 6 months or greater * 18 years of age or older * lab values as outlined in protocol * tumor blocks or slides must be available of either primary or metastatic tumor site for c-kit mutation testing * negative pregnancy test within 48 hours of starting treatment * at least one measurable site of disease as defined by at least 1cm in greatest dimension exclusion criteria: * severe and/or uncontrolled medical disease * pregnant or nursing mothers * known brain metastasis. history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening ct or mri scan * less than 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 cervical carcinoma in situ * grade iii/iv cardiac problems as defined by the new york heart association criteria * ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, qtc interval \>450msec for males of \>470 msec for females * hypertension that cannot be controlled by medication * any of the following within 12 months prior to starting treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism * nci ctcae version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment * concurrent treatment with warfarin * prior treatment with su011248 or any other antiangiogenic agent * no h2 blockers or proton pump inhibitors * known chronic liver disease * known hiv infection * previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 4 weeks prior to study entry * major surgery within 4 weeks prior to study entry * pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication

Keywords: sutent malignant melanoma