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Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
temozolomide
Brachytherapy
External Beam Radiation Therapy
Sponsored by
Methodist Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Brain Tumor, GBM, Glioblastoma Multiforme, Glioblastoma, Brachytherapy, Temozolomide, Temodar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme
  • Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection
  • Age 18 years or older
  • Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU
  • The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology
  • Karnofsky Performance Status (KPS) => 70
  • Negative pregnancy test if a female of childbearing age and not surgically sterilized
  • Male or female subject agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile)
  • Life expectancy > 3 months
  • Adequate laboratory results: ANC => 1.5 x 109/L. Platelets => 100 x 109/L
  • Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery

Exclusion Criteria:

  • Prior use of temozolomide
  • Presence or history of severe hepatic or renal impairment
  • Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting
  • Subject with prior intracranial malignancy
  • Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy
  • Subject has pacemaker or other MRI non-compatible metal in the body
  • Previous radiation to the head/neck or brain
  • Pregnant or lactating women
  • Patient has allergy to iodine and/or dacarbazine
  • Creatinine > 1.5x upper limits of normal (ULN), AST > 3x ULN
  • Chemotherapy within the last 6 months
  • Residual tumor >1 cm (in a single dimension) on baseline MRI scan (T1 post-gadolinium images)
  • Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic chiasm) on baseline MRI scan

Sites / Locations

  • Methodist University Hospital

Outcomes

Primary Outcome Measures

Treatment-related toxicity.

Secondary Outcome Measures

6 month, 1 year and overall survival.
Tumor progression.
Progression-free survival.
Quality of life.

Full Information

First Posted
September 13, 2006
Last Updated
September 17, 2009
Sponsor
Methodist Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00376103
Brief Title
Radiation Boost for Newly Diagnosed Glioblastoma Multiforme
Official Title
A Phase I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding from sponsor
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Methodist Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.
Detailed Description
The study design is multi-centered and non-randomized. Patients with newly diagnosed GBM undergoing initial surgical resection will be candidates for this study. Eligible patients will undergo surgical resection within 30 days of diagnosis. Newly diagnosed patients with presumed diagnosis of GBM will undergo surgery for maximal resection. After frozen section diagnosis of GBM is confirmed, the GliaSite® will be placed into the tumor cavity. After the patient recovers from surgery, radiation therapy (60 Gy to 1 cm) is delivered via the GliaSite®. Radiation therapy with the GliaSite® will be initiated within 21 days after surgery. Concomitant temozolomide (75 mg/m2/d) is started 2 days prior to radiation therapy with the GliaSite® and continued for a total of 7 days. Within 21 days following radiation therapy with the GliaSite®, external beam radiation therapy (60 Gy in 30 fractions) will be initiated. Concomitant temozolomide (75 mg/m2/d) will start on day 1 of external beam radiation therapy and continue through the external beam radiation therapy interval, ending with the last day of radiation. Four weeks (+/- 2 days) after completion of external beam radiation therapy, temozolomide (150 mg/m2/d) for 5 days every 28 days will be initiated for one cycle. At the start of cycle 2, the dose will be escalated to 200 mg/m2/d, if the CTC non-hematological toxicity for cycle 1 is Grade < 2 (except for alopecia, nausea and vomiting). This will continue for up to a total of 12 cycles, unless disease progression or severe myelosuppression is noted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Brain Tumor, GBM, Glioblastoma Multiforme, Glioblastoma, Brachytherapy, Temozolomide, Temodar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
75 mg/m2/day
Intervention Type
Procedure
Intervention Name(s)
Brachytherapy
Intervention Description
60 Gy to 1 cm
Intervention Type
Procedure
Intervention Name(s)
External Beam Radiation Therapy
Intervention Description
60 Gy
Primary Outcome Measure Information:
Title
Treatment-related toxicity.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
6 month, 1 year and overall survival.
Time Frame
End of study
Title
Tumor progression.
Time Frame
End of study
Title
Progression-free survival.
Time Frame
End of study
Title
Quality of life.
Time Frame
End of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection Age 18 years or older Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology Karnofsky Performance Status (KPS) => 70 Negative pregnancy test if a female of childbearing age and not surgically sterilized Male or female subject agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile) Life expectancy > 3 months Adequate laboratory results: ANC => 1.5 x 109/L. Platelets => 100 x 109/L Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery Exclusion Criteria: Prior use of temozolomide Presence or history of severe hepatic or renal impairment Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting Subject with prior intracranial malignancy Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy Subject has pacemaker or other MRI non-compatible metal in the body Previous radiation to the head/neck or brain Pregnant or lactating women Patient has allergy to iodine and/or dacarbazine Creatinine > 1.5x upper limits of normal (ULN), AST > 3x ULN Chemotherapy within the last 6 months Residual tumor >1 cm (in a single dimension) on baseline MRI scan (T1 post-gadolinium images) Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic chiasm) on baseline MRI scan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen K Sills, MD
Organizational Affiliation
Methodist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

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Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

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