Clinical Trial: SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:

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.

Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: 2-month Progression-free Survival Rate [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months. ]

2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.


Original Primary Outcome:

  • To determine the response rate of this patient population to treatment with SU011248 [ Time Frame: 2 years ]
  • To determine the time to progression of this patient population to treatment with SU011248 [ Time Frame: Years ]


Current Secondary Outcome:

  • Best Overall Response Rate [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles. ]
    The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
  • Overall Survival [ Time Frame: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m). ]
    Overall survival (OS) is defined as the time from study entry to death or date last known alive.
  • Time to Progression [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles). ]
    Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.


Original Secondary Outcome:

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: December 18, 2007
Date Started: August 2007
Date Completion:
Last Updated: October 16, 2016
Last Verified: June 2016