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Topotecan in Treating Patients With Refractory or Progressive Primary Malignant Brain Tumors

2014-08-27 03:44:47 | BioPortfolio

Summary

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.

Description

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

topotecan hydrochloride

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York
New York
United States
10032

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:47-0400

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Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.

A group of malignant tumors of the nervous system that feature primitive cells with elements of neuronal and/or glial differentiation. Use of this term is limited by some authors to central nervous system tumors and others include neoplasms of similar origin which arise extracranially (i.e., NEUROECTODERMAL TUMORS, PRIMITIVE, PERIPHERAL). This term is also occasionally used as a synonym for MEDULLOBLASTOMA. In general, these tumors arise in the first decade of life and tend to be highly malignant. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, p2059)

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