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.
Interventional
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.
2 years
No
Andrew J. Wagner, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
10-179
NCT01207492
September 2010
Name | Location |
---|---|
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 |