Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Novartis
Information provided by (Responsible Party):	F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00424515

Purpose

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.

Condition	Intervention	Phase
Mucosal Melanoma Acral/Lentiginous Melanoma Chronically Sun Damaged Melanomas	Drug: Imatinib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To correlate c-kit mutational status with response to therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to evaluate the tolerability of Gleevec in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	27
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: Gleevec

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424515

Locations

United States, California
The Angeles Clinic and Research Institute
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado at Denver Health Sciences Center
Denver, Colorado, United States, 80045
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Hampshire
Norris Cotton Cancer Center-Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States

Sponsors and Collaborators

Dana-Farber Cancer Institute

Novartis

Investigators

Principal Investigator:

F. Stephen Hodi, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	F. Stephen Hodi, MD, Melanoma Disease Center Director, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00424515 History of Changes
Other Study ID Numbers:	06-056
Study First Received:	January 18, 2007
Last Updated:	October 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Imatinib
Gleevec

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012