PI/II of Temozolomide & Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01120639
First received: May 7, 2010
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy with the FDA approved chemotherapy drug temozolomide


Condition Intervention Phase
Glioblastoma
Cancer of Brain and Nervous System
Glioblastoma Multiforme
Drug: Temozolomide
Procedure: Stereotactic Radiosurgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Determine the progression-free survival rate. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the short- and long-term adverse effects. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Determine the radiographic response rate. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Determine the overall survival rate. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Perform patterns of failure analysis. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Assess quality of life during treatment. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTV (Planning Target Volume) less than 60 cm3

Hypofractionated radiotherapy with concurrent temozolomide

Dose Levels:

  1. 25 Gy in 5 fractions
  2. 30 Gy in 5 fractions
  3. 35 Gy in 5 fractions
  4. 40 Gy in 5 fractio
Drug: Temozolomide
75 mg/m2/day, oral
Other Names:
  • Temodar
  • Temodal
Procedure: Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Experimental: PTV (Planning Target Volume) between 60 and 150 cm3

Hypofractionated radiotherapy with concurrent temozolomide

Dose Levels:

  1. 25 Gy in 5 fractions
  2. 30 Gy in 5 fractions
  3. 35 Gy in 5 fractions
  4. 40 Gy in 5 fractions
Drug: Temozolomide
75 mg/m2/day, oral
Other Names:
  • Temodar
  • Temodal
Procedure: Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
  • The tumor must be supratentorial in location
  • The planning target volume (tumor plus margin) must measure <= 150 cm^3 in volume
  • Age >=18 years
  • Life expectancy of at least 12 weeks
  • Patient must have adequate organ function to tolerate temozolomide (details in the protocol)

Exclusion Criteria:

  • Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
  • Tumor foci detected below the tentorium
  • Multifocal disease or leptomeningeal spread
  • Prior allergic reaction to the study drugs involved in this protocol
  • Patients with pacemaker will be allowed to undergo CT instead of MRI
  • Pediatric patients (age <18), pregnant women, and nursing patients will be excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120639

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Alice Banh    650-723-1423    aliceb@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Scott Soltys         
Sub-Investigator: Dr Lawrence Recht         
Sub-Investigator: Griffith R. Harsh         
Sub-Investigator: Iris Catrice Gibbs         
Sub-Investigator: Clara Choi         
Sub-Investigator: Steven Daniel Chang         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Scott Soltys Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01120639     History of Changes
Other Study ID Numbers: BRN0012, SU-04202010-5726, 17774
Study First Received: May 7, 2010
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014