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Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376103
Recruitment Status : Terminated (Loss of funding from sponsor)
First Posted : September 14, 2006
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Methodist Healthcare

Tracking Information
First Submitted Date  ICMJE September 13, 2006
First Posted Date  ICMJE September 14, 2006
Last Update Posted Date September 18, 2009
Study Start Date  ICMJE August 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
Treatment-related toxicity. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2006)
Treatment-related toxicity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
  • 6 month, 1 year and overall survival. [ Time Frame: End of study ]
  • Tumor progression. [ Time Frame: End of study ]
  • Progression-free survival. [ Time Frame: End of study ]
  • Quality of life. [ Time Frame: End of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2006)
  • 6 month, 1 year and overall survival.
  • Tumor progression.
  • Progression-free survival.
  • Quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Boost for Newly Diagnosed Glioblastoma Multiforme
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: temozolomide
    75 mg/m2/day
    Other Name: Temodar
  • Procedure: Brachytherapy
    60 Gy to 1 cm
  • Procedure: External Beam Radiation Therapy
    60 Gy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 9, 2008)
3
Original Enrollment  ICMJE
 (submitted: September 13, 2006)
60
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376103
Other Study ID Numbers  ICMJE MHIRB 2006-032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allen Sills, MD, Methodist Healthcare
Study Sponsor  ICMJE Methodist Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allen K Sills, MD Methodist University Hospital
PRS Account Methodist Healthcare
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP