Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, September 2008
Sponsors and Collaborators: Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Pfizer
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00577382
  Purpose

The purpose of this study is to evaluate how effective SU011248 works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. SU011248 is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.


Condition Intervention Phase
Mucosal Melanoma
Acral/Lentiginous Melanoma
Drug: SU011248
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Sunitinib Sunitinib malate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

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

Primary Outcome Measures:
  • To determine the response rate of this patient population to treatment with SU011248 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the time to progression of this patient population to treatment with SU011248 [ Time Frame: Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SU011248
    Oral pill taken daily for 4 weeks
Detailed Description:
  • Participants will be given a bottle of SU011248 pills and will be asked to take pills once daily for 4 weeks followed by a rest period of two weeks. This 6 week period is called a cycle.
  • During all treatment cycles, participants will have a physical exam and undergo blood tests at every visit.
  • After a month of receiving the study drug participants will undergo a repeat PET scan to see if the drug has caused any early changes to their cancer.
  • At week 5 a repeat chest, abdomen and pelvic CT will be performed.
  • Participants will be on this research 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:

  • History of primary mucosal or acral/lentiginous melanoma
  • Histologically documented stage III unresectable or IV metastatic melanoma
  • ECOG Performance Status 0,1 or 2
  • Estimated life expectancy of 6 months or greater
  • 18 years of age or older
  • Lab values as outlined in protocol
  • Tumor blocks or slides must be available of either primary or metastatic tumor site for c-kit mutation testing
  • Negative pregnancy test within 48 hours of starting treatment
  • At least one measurable site of disease as defined by at least 1cm in greatest dimension

Exclusion Criteria:

  • Severe and/or uncontrolled medical disease
  • Pregnant or nursing mothers
  • Known brain metastasis. History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan
  • Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in situ
  • Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
  • Ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, QTc interval >450msec for males of >470 msec for females
  • Hypertension that cannot be controlled by medication
  • Any of the following within 12 months prior to starting treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
  • NCI CTCAE version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
  • Concurrent treatment with warfarin
  • Prior treatment with SU011248 or any other antiangiogenic agent
  • No H2 blockers or proton pump inhibitors
  • Known chronic liver disease
  • Known HIV infection
  • Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 4 weeks prior to study entry
  • Major surgery within 4 weeks prior to study entry
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577382

Contacts
Contact: F. Stephen Hodi, MD 617-632-5053 shodi@partners.org
Contact: Suzanne MacRae, RN 617-632-5906 smacrae@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: F. Stephen Hodi, MD            
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Donald Lawrence, MD            
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: David McDermott, MD            
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States
Contact: Jeffrey Sosman, MD     800-811-8480        
Principal Investigator: Jeffrey Sosman, MD            
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Pfizer
Investigators
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Dana-Farber Cancer Institute ( F. Stephen Hodi, MD )
Study ID Numbers: 06-145
Study First Received: December 18, 2007
Last Updated: September 15, 2008
ClinicalTrials.gov Identifier: NCT00577382  
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Sutent
malignant melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Sunitinib
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009