SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Brief Title

SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Official Title

A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Brief Summary

      The purpose of this study is to evaluate how effective Sunitinib works in treating acral
      lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib 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.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  To determine the proportion of participants with metastatic mucosal or acral/lentiginous
           melanoma who are alive and without disease progression at two months after beginning
           treatment with sunitinib.

        -  To determine the best overall response rate.

      Secondary

        -  To determine the time to progression and overall survival.

        -  To correlate c-kit mutational status with response to therapy.

        -  To evaluate the use of FDG-PET scanning in determining early biologic response to
           therapy.

        -  To assess amplification of c-kit status through quantitative PCR and/or FISH and other
           related molecular pathway targets.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

2-month Progression-free Survival Rate

Secondary Outcome

 Best Overall Response Rate

Condition

Mucosal Lentiginous Melanoma

Intervention

Sunitinib

Study Arms / Comparison Groups

 Sunitinib

Description:  Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

52

Start Date

August 2007

Completion Date

August 2014

Primary Completion Date

August 2014

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

F. Stephen Hodi, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00577382

Organization ID

06-145

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Beth Israel Deaconess Medical Center

Study Sponsor

F. Stephen Hodi, MD, Principal Investigator, Dana-Farber Cancer Institute

Verification Date

June 2016