A Phase II Study of Dasatinib in Patients with Inoperable Locally Advanced or Metastatic c-KIT-Positive Acral or Mucosal Melanoma

Protocol
13-100
Full Title
A Phase II Trial of Dasatinib in Kit-Positive Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas (ECOG E2607)
Phase
II
Purpose

Acral melanomas occur on the palms, soles of the feet, or underneath the fingernails. Mucosal melanomas arise in the mouth, sinuses, rectum, vulva, or vagina. The purpose of this study is to evaluate the safety and effectiveness of a drug called dasatinib in patients with acral, vulvovaginal, or other mucosal melanoma that is locally advanced and cannot be surgically removed, or has spread to other parts of the body.

Dasatinib is approved for treating a form of leukemia, but its use in melanoma is considered investigational. It works against cancer by targeting a mutated form of a protein called c-KIT, which drives cancer growth. Dasatinib is taken orally (by mouth).

Co-Investigators

Carvajal, Richard, MD

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have acral, vulvovaginal, or other mucosal melanoma that is inoperable and locally advanced or has spread to other parts of the body.
  • Patients’ melanomas must be positive for mutated c-KIT.
  • For patients who have received prior therapy, at least 4 weeks must have passed since completion of treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mario Leitao at 212-639-3987.

Disease(s)
Melanoma
Vulvar Cancer
Locations
Related Diseases