Preoperative Chemoradiation for Glioblastoma

Glioblastoma Clinical Trial

Official title:

Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092038
• Other study ID #: TGH0001
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2014
• Last updated: November 7, 2015
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Tampa General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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
• craniotomy and tumor resection
maximal safe resection

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tampa General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0	comparison of toxicity related to experimental treatment to historical local controls	up to up to 16 weeks	Yes
Secondary	Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples	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.	at enrollment	No
Secondary	progression free survival		up to 12 months	No
Secondary	overall survival		up to 12 months	No