Conditions: Mucosal Lentiginous Melanoma Acral Lentiginous Malignant Melanoma
Keywords: Sutent malignant melanoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: None

Protocol document: