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Preoperative Chemoradiation for Glioblastoma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02092038
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tampa General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lawrence Berk, MD, PhD
Principal Investigator Affiliation	Tampa General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

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

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tampa General Hospital, Tampa, Florida

Status

Address

Tampa General Hospital

Tampa, Florida, 33606

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