NCT02092038

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

March 11, 2014

Last Update Submit

November 7, 2015

Conditions

Glioblastoma

Keywords

glioblastomatemozolomideradiation therapyradiotherapysurgerypre-operativeneoadjuvant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples

    at enrollment

  • progression free survival

    up to 12 months

  • overall survival

    up to 12 months

Study Arms (1)

Preoperative chemoradiation

EXPERIMENTAL

Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide

Drug: TemozolomideRadiation: partial brain irradiationProcedure: stereotactic biopsy of brain tumorProcedure: craniotomy and tumor resection

Interventions

TemozolomideDRUG

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

Also known as: Temodar
Preoperative chemoradiation
partial brain irradiationRADIATION

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

Preoperative chemoradiation
stereotactic biopsy of brain tumorPROCEDURE

will be assessed for tumor type and tumor markers

Preoperative chemoradiation
craniotomy and tumor resectionPROCEDURE

maximal safe resection

Preoperative chemoradiation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unresectable tumor
  • Absolute neutrophil count (ANC) less than 1,200/μL
  • Hemoglobin less than 9.0g/dL
  • Platelet count less than 100,000/μL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

TemozolomideCraniotomy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Lawrence Berk, MD, PhD

    Tampa General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 19, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

US(1)