SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Massachusetts General Hospital; Pfizer
• Treatments: Sunitinib

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