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Preoperative Chemoradiation for Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02092038
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Tampa General Hospital

Tracking Information
First Submitted Date  ICMJE March 11, 2014
First Posted Date  ICMJE March 19, 2014
Last Update Posted Date November 10, 2015
Study Start Date  ICMJE November 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0 [ Time Frame: up to up to 16 weeks ]
comparison of toxicity related to experimental treatment to historical local controls
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
  • Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples [ Time Frame: at enrollment ]
    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 [ Time Frame: up to 12 months ]
  • overall survival [ Time Frame: up to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Chemoradiation for Glioblastoma
Official Title  ICMJE Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: Temozolomide
    Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
    Other Name: Temodar
  • Radiation: partial brain irradiation
    Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
  • Procedure: stereotactic biopsy of brain tumor
    will be assessed for tumor type and tumor markers
  • Procedure: craniotomy and tumor resection
    maximal safe resection
Study Arms  ICMJE Experimental: Preoperative chemoradiation
Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
Interventions:
  • Drug: Temozolomide
  • Radiation: partial brain irradiation
  • Procedure: stereotactic biopsy of brain tumor
  • Procedure: craniotomy and tumor resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2015)
1
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2014)
20
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02092038
Other Study ID Numbers  ICMJE TGH0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tampa General Hospital
Study Sponsor  ICMJE Tampa General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lawrence Berk, MD, PhD Tampa General Hospital
PRS Account Tampa General Hospital
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP