Mucosal Melanoma Clinical Trial
— BUS255Official title:
A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.
Verified date | June 2016 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | August 2016 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | University of Chicago | Chicago | Illinois |
United States | University of Colorado at Denver Health Sciences Center | Denver | Colorado |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the response rate of patients with metastatic mucosal or acral/lentiginous melanoma and chronically sundamaged melanomas to treatment with Gleevec and also to determine the time to progression. | 2 years | No | |
Secondary | To correlate c-kit mutational status with response to therapy | 2 years | No | |
Secondary | to evaluate the tolerability of Gleevec in this patient population. | 2 years | Yes |
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