Glioblastoma
Conditions
Keywords
glioblastoma, temozolomide, radiation therapy, radiotherapy, surgery, pre-operative, neoadjuvant
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.
Interventions
DRUGTemozolomide
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
RADIATIONpartial brain irradiation
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
PROCEDUREstereotactic biopsy of brain tumor
will be assessed for tumor type and tumor markers
PROCEDUREcraniotomy and tumor resection
maximal safe resection
Sponsors
Tampa General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0 | up to up to 16 weeks | comparison of toxicity related to experimental treatment to historical local controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples | 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 | up to 12 months | — |
| overall survival | up to 12 months | — |
Countries
United States
Outcome results
None listed