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Preoperative Chemoradiation for Glioblastoma

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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

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

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Temozolomide Radiation: partial brain irradiation Procedure: stereotactic biopsy of brain tumor Procedure: craniotomy and tumor resection Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
Study Start Date : November 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Preoperative chemoradiation
Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. progression free survival [ Time Frame: up to 12 months ]
  3. overall survival [ Time Frame: up to 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092038


Locations
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Tampa General Hospital
Investigators
Principal Investigator: Lawrence Berk, MD, PhD Tampa General Hospital

Responsible Party: Tampa General Hospital
ClinicalTrials.gov Identifier: NCT02092038     History of Changes
Other Study ID Numbers: TGH0001
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Tampa General Hospital:
glioblastoma
temozolomide
radiation therapy
radiotherapy
surgery
pre-operative
neoadjuvant

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents