search
Back to results

Preoperative Chemoradiation for Glioblastoma

Primary Purpose

Glioblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Temozolomide
partial brain irradiation
stereotactic biopsy of brain tumor
craniotomy and tumor resection
Sponsored by
Tampa General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring glioblastoma, temozolomide, radiation therapy, radiotherapy, surgery, pre-operative, neoadjuvant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative chemoradiation

Arm Description

Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide

Outcomes

Primary Outcome Measures

toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0
comparison of toxicity related to experimental treatment to historical local controls

Secondary Outcome Measures

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.
progression free survival
overall survival

Full Information

First Posted
March 11, 2014
Last Updated
November 7, 2015
Sponsor
Tampa General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02092038
Brief Title
Preoperative Chemoradiation for Glioblastoma
Official Title
Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampa General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
glioblastoma, temozolomide, radiation therapy, radiotherapy, surgery, pre-operative, neoadjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoperative chemoradiation
Arm Type
Experimental
Arm Description
Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
Intervention Type
Radiation
Intervention Name(s)
partial brain irradiation
Intervention Description
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
Intervention Type
Procedure
Intervention Name(s)
stereotactic biopsy of brain tumor
Intervention Description
will be assessed for tumor type and tumor markers
Intervention Type
Procedure
Intervention Name(s)
craniotomy and tumor resection
Intervention Description
maximal safe resection
Primary Outcome Measure Information:
Title
toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0
Description
comparison of toxicity related to experimental treatment to historical local controls
Time Frame
up to up to 16 weeks
Secondary Outcome Measure Information:
Title
Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples
Description
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
Title
progression free survival
Time Frame
up to 12 months
Title
overall survival
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Berk, MD, PhD
Organizational Affiliation
Tampa General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Preoperative Chemoradiation for Glioblastoma

We'll reach out to this number within 24 hrs