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SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Pfizer
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00577382
First received: December 18, 2007
Last updated: February 24, 2014
Last verified: February 2014
  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 Lentiginous Melanoma
Acral Lentiginous Malignant Melanoma
Drug: Sunitinib
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 SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Resource links provided by NLM:


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: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib Drug: Sunitinib
Oral pill taken daily for 4 weeks
Other Names:
  • Sutent
  • SU011248

Detailed Description:
  • Participants will be given a bottle of SU011248 pills and will be asked to take pills once daily for 28 days on an ongoing basis. Participants will return every 28 days for new pills.
  • 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 8 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
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: NCT00577382

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
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

No publications provided

Responsible Party: F. Stephen Hodi, MD, Melanoma Disease Center Director, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00577382     History of Changes
Other Study ID Numbers: 06-145
Study First Received: December 18, 2007
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014