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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00424515
Other study ID # 06-056
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received January 18, 2007
Last updated June 8, 2016
Start date July 2006
Est. completion date August 2016

Study information

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

Clinical Trial 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. 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.


Description:

- 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.


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Imatinib
Participants will take four 100mg tablets once daily for approximately one year (Dosage may be increased to twice daily if disease worsens)

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute Novartis

Country where clinical trial is conducted

United States, 

Outcome

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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