Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Novartis
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis

• History of primary mucosal or acral/lentiginous melanoma

• Histologically documented stage IV metastatic melanoma

• ECOG performance status 0,1, or 2

• Estimated life expectancy of 6 months or greater

• Age 18 years or older

• Creatinine < 1.5 x ULN

• ANC > 1500 ul

• Platelets > 100,000 ul

• Total bilirubin, AST, and ALT < 2 x ULN

• Amylase and lipase < 1.5 x ULN

• C-kit mutation documented from either primary or metastatic tumor site

• > 4 weeks from prior chemotherapy or investigational drug

• At least one measurable site of disease as defined by at least 1 cm in greatest dimension

Exclusion Criteria:

• Severe and/or uncontrolled medical disease

• Pregnant or nursing mothers

• Any other significant medical, surgical, or psychiatric condition that my interfere with compliance

• Patient is < 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ

• Concurrent treatment with Warfarin

• Prior treatment with c-kit inhibitor

• Patient with Grade III/IV cardiac problems as defined by NYHA criteria

• No H2 blockers or proton pump inhibitors

• Known brain metastasis

• Known chronic liver disease

• Known diagnosis of HIV infection

• Previous radiotherapy to > 25% of the bone marrow

• Major surgery within 2 weeks prior to study entry

• Patient has received any other investigational agent within 28 days of first study drug dosing

• Chemotherapy within 4 weeks prior to study entry