Topotecan in Treating Patients With Refractory or Progressive Primary Malignant Brain Tumors
| Status: | Archived |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2003 |
A Phase I Study of Topotecan by Convection Enhanced Delivery (Intracerebral Clysis) for the Treatment of Recurrent Primary Malignant Brain Tumors
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
topotecan directly into the tumor and surrounding tissue may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of topotecan infused directly into
the tumor and surrounding tissue in treating patients with refractory or progressive primary
malignant brain tumors.
OBJECTIVES:
- Evaluate the safety and effectiveness of convection enhanced delivery (intracerebral
clysis [ICC]) therapy comprising topotecan hydrochloride in patients with refractory or
progressive primary malignant brain tumors.
- Apply advanced MRI as a noninvasive means of optimizing treatment parameters and
determining volume of drug distribution with convection enhanced delivery.
- Determine whether the expression of the topoisomerase target in the tumor influences
response to topotecan hydrochloride.
OUTLINE: This is an open-label study.
Patients undergo placement of two catheters inserted directly into the tumor and surrounding
tissue. Patients receive topotecan hydrochloride via convection enhanced delivery
continuously for up to 5 days. Patients are monitored daily for response and drug
distribution by MRI.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
We found this trial at
1
site
701 West 168th Street
New York, New York 10032
New York, New York 10032
(212) 851-4680
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center The Herbert Irving Comprehensive Cancer...
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