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Radiosurgery, Bevacizumab, and Irinotecan Hydrochloride in Treating Patients With Recurrent Glioblastoma

2014-08-27 03:15:16 | BioPortfolio

Summary

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of glioblastoma by blocking blood flow to the tumor. Drugs used in chemotherapy such as irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiosurgery together with bevacizumab and irinotecan hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving radiosurgery together with bevacizumab and irinotecan hydrochloride works in treating patients with recurrent glioblastoma.

Description

PRIMARY OBJECTIVES:

I. To determine the overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery

SECONDARY OBJECTIVES:

I. To evaluate the toxicities of the combination of bevacizumab, irinotecan and radiosurgery.

II. To evaluate the progression-free survival of patients treated with bevacizumab, irinotecan and radiosurgery.

OUTLINE:

Patients receive bevacizumab IV over 30 minutes on days 1 and 15. Patients also receive irinotecan hydrochloride IV on days 1 and 15 beginning in course 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo radiosurgery 10-14 days after beginning bevacizumab.

After completion of study treatment, patients are followed for 18 months.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioblastoma

Intervention

radiosurgery, bevacizumab, irinotecan hydrochloride

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland
Ohio
United States
44195

Status

Recruiting

Source

Case Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:16-0400

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Medical and Biotech [MESH] Definitions

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

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