Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

Mucosal Melanoma Clinical Trial

— BUS255  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00424515
• Other study ID #: 06-056
• 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

• Acral/Lentiginous Melanoma
• Chronically Sun Damaged Melanomas
• Melanoma
• Mucosal Melanoma

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