NCT00424515

Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (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 imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.

Detailed description

OBJECTIVES: Primary * To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib. * To determine the time to progression. Secondary * 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. * Tolerability of imatinib. * To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets. * To correlate c-kit amplification status with response to therapy.

Conditions

• Mucosal Melanoma
• Acral/Lentiginous Melanoma
• Chronically Sun Damaged Melanomas

Interventions

Type	Name	Description
DRUG	Imatinib	Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2007-01-19
• Last updated: 2016-12-08
• Results posted: 2016-12-08

Locations

5 sites across 1 country: United States