Status:
COMPLETED
Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Novartis
Conditions:
Mucosal Melanoma
Acral/Lentiginous Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ca...
Detailed Description
OBJECTIVES: Primary * To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib. * To determine the ti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00424515
Start Date
July 1 2006
End Date
July 1 2011
Last Update
December 8 2016
Active Locations (5)
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1
University of Colorado at Denver Health Sciences Center
Denver, Colorado, United States, 80045
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115