NCT00577382

SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucosal Lentiginous Melanoma
• Acral Lentiginous Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Sunitinib

Timeline

• Start date: 2007-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2007-12-20
• Last updated: 2016-12-08
• Results posted: 2016-12-08

Locations

5 sites across 1 country: United States