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

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Novartis
Information provided by:	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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:	July 2010
Estimated Primary Completion Date:	July 2010 (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)

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

Contacts

Contact: F. Stephen Hodi, MD

617-632-5053

fhodi@partners.org

Locations

United States, California
The Angeles Clinic and Research Institute	Recruiting
Santa Monica, California, United States, 90404
Contact: Steven O'Day, MD 310-231-2122 soday@theangelesclinic.org
Principal Investigator: Steven O'Day, MD
Sub-Investigator: Omid Hamid, MD
United States, Colorado
University of Colorado at Denver Health Sciences Center	Recruiting
Denver, Colorado, United States, 80045
Contact: Mary Cook, RN 720-848-0624 mary.m.cook@uchsc.edu
Principal Investigator: Rene Gonzalez, MD
United States, Florida
H. Lee Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Contact: Susan Rivers, RN 813-745-3558 susan.rivers@moffitt.org
Principal Investigator: Jeffrey Weber, MD,PhD
United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Thomas Gajewski, MD, PHD tgajewsk@medicine.bsd.uchicago.edu
Contact: Karen Matijevich, RN 773-702-0725 kmatijev@medicine.bsd.uchicago.edu
Principal Investigator: Thomas Gajewski, MD, PHD
United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Suzanne MacRae, RN 617-632-5906 suzanne_mac_rae@dfci.harvard.edu
Contact: Laurie Chiambalero, RN 617-632-5789 laurie_chiambalero@dfci.harvard.edu
Principal Investigator: Stephen Hodi, MD
Sub-Investigator: Philip Friedlander, MD, PHD
United States, New Hampshire
Norris Cotton Cancer Center-Dartmouth Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States
Contact: Marc Ernstoff, MD Marc.S.Ernstoff@Hitchcock.ORG
Principal Investigator: Marc Ernstoff, MD
United States, North Carolina
University of North Carolina at Chapel Hill School of Medicine	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Lucille Purser, RN 919-966-4432 lpurser@med.unc.edu
Principal Investigator: Frances A Collichio, M.D.
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States
Contact: Michelle Glass, RN 713-792-3850 mglass@mdanderson.org
Principal Investigator: Kevin Kim, MD

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:	Dana-Farber Cancer Institute ( F.Stephen Hodi, MD )
Study ID Numbers:	06-056
Study First Received:	January 18, 2007
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00424515 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Imatinib
Gleevec

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Melanoma

Neuroendocrine Tumors
Imatinib
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2009