A Multi-Center Single Agent Phase II Study of the Efficacy of Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor
- In this research study, each cycle of study drug dosing will last 4 weeks (28 days).
During each cycle, participants will take nilotinib by mouth twice daily. During the
first cycle, participants will come to the clinic on Days 1 and 8. For Cycles 2-4 and
every 3 cycles thereafter, they will come to the clinic on Day 1.
- The following tests and procedures will be performed at specific time points during
study treatment: MRI or CT scans; physical examinations; vital signs; blood work;
questionnaires and EKG.
- Participants may continue in this research study for as long as they do not have
serious side effects or their disease does not get worse.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
To estimate progression free survival at 6 months in participants with recurrent PVNS treated with nilotinib.
Andrew J. Wagner, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Stanford University Medical Center||Stanford, California 94305-5408|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|H. Lee Moffitt Cancer Center||Tampa, Florida 33612|
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|Sarcoma Oncology Center||Santa Monica, California 90403|