Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

Condition(s) targeted: Mucosal Melanoma; Acral/Lentiginous Melanoma; Chronically Sun Damaged Melanomas

Intervention: Imatinib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
F. Stephen Hodi, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

Overall contact:
F. Stephen Hodi, MD, Phone: 617-632-5053, Email: fhodi@partners.org

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.

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.

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To correlate c-kit mutational status with response to therapy

to evaluate the tolerability of Gleevec in this patient population.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

F. Stephen Hodi, MD, Phone: 617-632-5053, Email: fhodi@partners.org

The Angeles Clinic and Research Institute, Santa Monica, California 90404, United States; Recruiting
Steven O'Day, MD, Phone: 310-231-2122, Email: soday@theangelesclinic.org
Steven O'Day, MD, Principal Investigator
Omid Hamid, MD, Sub-Investigator

University of Colorado at Denver Health Sciences Center, Denver, Colorado 80045, United States; Recruiting
Mary Cook, RN, Phone: 720-848-0624, Email: mary.m.cook@uchsc.edu
Rene Gonzalez, MD, Principal Investigator

H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States; Recruiting
Susan Rivers, RN, Phone: 813-745-3558, Email: susan.rivers@moffitt.org
Jeffrey Weber, MD,PhD, Principal Investigator

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Thomas Gajewski, MD, PHD, Email: tgajewsk@medicine.bsd.uchicago.edu
Karen Matijevich, RN, Phone: 773-702-0725, Email: kmatijev@medicine.bsd.uchicago.edu
Thomas Gajewski, MD, PHD, Principal Investigator

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Colleen Lawrence, RN, Phone: 617-632-5789, Email: colleen_lawrence@dfci.harvard.edu
Stephen Hodi, MD, Principal Investigator
Philip Friedlander, MD, PHD, Sub-Investigator

Norris Cotton Cancer Center-Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States; Recruiting
Marc Ernstoff, MD, Email: Marc.S.Ernstoff@Hitchcock.ORG
Marc Ernstoff, MD, Principal Investigator

University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina 27599, United States; Recruiting
Lucille Purser, RN, Phone: 919-966-4432, Email: lpurser@med.unc.edu
Frances A Collichio, M.D., Principal Investigator

MD Anderson Cancer Center, Houston, Texas, United States; Recruiting
Michelle Glass, RN, Phone: 713-792-3850, Email: mglass@mdanderson.org
Kevin Kim, MD, Principal Investigator

Starting date: July 2006
Last updated: May 25, 2010