Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2006
End Date:August 2016

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A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.

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. Gleevec is a protein-kinase inhibitor. It
is believed that Gleevec may be effective in blocking signals on certain cancer cells which
allow the malignant cells to multiply and spread.

- If tests show that the patient is eligible and they choose to participate in the study,
they will receive a bottle of Gleevec pills. Each pill will be 100mg and the
participant will take 4 pills once daily (400mg). The dose may increase to 400mg twice
a day if the participant's cancer worsens.

- The following study procedures will also be performed at routine intervals throughout
the course of treatment: blood tests, medical history updates; physical exams, Positron
Emission tomography (PET) scan, and Chest/Abdomen/Pelvic CT.

- Participants will be on this study for approximately one year.

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
We found this trial at
5
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Denver, CO
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Houston, Texas 77030
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Houston, TX
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Tampa, Florida 33612
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Tampa, FL
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