The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
* Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks. * During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed. * At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body. * After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain. * At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Given intravenously over approximately 30 minutes once every 3 weeks
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Objective Response Rate in the Central Nervous System (CNS)
Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.
Time frame: 2 years
Number of Subjects With Adverse Events (Any Grade)
Adverse events per NCI CTCAE
Time frame: 2 years
Objective Response Rate in Non-Central Nervous System (CNS) Sites
Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
Time frame: 2 years
Time to Progression at Any Site.
Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0
Time frame: 2 years
Clinical Benefit Rate.
CBR = CR + PR + SD \> 24 weeks in CNS with at least stable non-CNS disease
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.