Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

Completed · Phase 2

Conditions studied: Mucosal Melanoma, Acral/Lentiginous Melanoma, Chronically Sun Damaged Melanomas

In brief

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.

Key facts

Study ID

NCT00424515

Run by

Dana-Farber Cancer Institute

People needed

24

Starts

2006-07-01

Expected to finish

2011-07-01

Last updated by the study team

2016-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado at Denver Health Sciences Center — Denver, Colorado, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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