A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.
- If tests show that the patient is eligible and they choose to participate in the study,
they will receive a bottle of Gleevec pills. Each pill will be 100mg and the
participant will take 4 pills once daily (400mg). The dose may increase to 400mg twice
a day if the participant's cancer worsens.
- The following study procedures will also be performed at routine intervals throughout
the course of treatment: blood tests, medical history updates; physical exams, Positron
Emission tomography (PET) scan, and Chest/Abdomen/Pelvic CT.
- Participants will be on this study for approximately one year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate of patients with metastatic mucosal or acral/lentiginous melanoma and chronically sundamaged melanomas to treatment with Gleevec and also to determine the time to progression.
2 years
No
F. Stephen Hodi, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
06-056
NCT00424515
July 2006
June 2013
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
University of Chicago | Chicago, Illinois 60637 |
University of Colorado at Denver Health Sciences Center | Denver, Colorado 80045 |