Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (BUS255)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00424515
First received: January 18, 2007
Last updated: February 24, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: 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:


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 ]

Enrollment: 24
Study Start Date: July 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Imatinib
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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, 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 by Dana-Farber Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: February 24, 2014
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 September 18, 2014