Tampa General Hospital
Tampa, Florida, 33606, United States
NCT Number: NCT02092038
Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Tampa, Florida, 33606, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
Other names: Temodar
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
will be assessed for tumor type and tumor markers
maximal safe resection
Time frame: up to up to 16 weeks
comparison of toxicity related to experimental treatment to historical local controls
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.
Time frame: up to 12 months
Time frame: up to 12 months
Tampa General Hospital
Other
Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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