Preoperative Chemoradiation for Glioblastoma

Phase 1CompletedNCT02092038

Tampa General Hospital1 enrolled

Overview

Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery. Imaging: MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery. MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma

Interventions

TemozolomideDRUG

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

partial brain irradiationRADIATION

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

stereotactic biopsy of brain tumorPROCEDURE

will be assessed for tumor type and tumor markers

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population) * WHO performance status 0-2 (to allow comparison to historical controls) * Adequate hematological parameters: (for safety because of neutropenia from the temozolomide) * Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent) * Able to have MRI scans (secondary endpoint is MRI scan characteristics) * Willing to have radiation treatment at a participating center (homogeneity of treatment parameters) * Ages 18-80 Exclusion Criteria: * Unresectable tumor * Absolute neutrophil count (ANC) less than 1,200/μL * Hemoglobin less than 9.0g/dL * Platelet count less than 100,000/μL

Locations (1)

Tampa General Hospital

Tampa, Florida, United States

Outcomes

Primary Outcomes

toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0

comparison of toxicity related to experimental treatment to historical local controls

Time frame: up to up to 16 weeks

Secondary Outcomes

Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples

determination of the feasibility of using standard MGMT activity measurement techniques on stereotactic specimens and comparison of the results with the results from the full resection.

Time frame: at enrollment

progression free survival

Time frame: up to 12 months

overall survival

Time frame: up to 12 months

Data from ClinicalTrials.gov

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