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Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: temozolomide Procedure: Brachytherapy Procedure: External Beam Radiation Therapy Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2006
Actual Primary Completion Date : March 2008

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Arms and Interventions
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Intervention Details:
  • Drug: temozolomide
    75 mg/m2/day
    Other Name: Temodar
  • Procedure: Brachytherapy
    60 Gy to 1 cm
  • Procedure: External Beam Radiation Therapy
    60 Gy

Outcome Measures
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Primary Outcome Measures :
  1. Treatment-related toxicity. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 6 month, 1 year and overall survival. [ Time Frame: End of study ]
  2. Tumor progression. [ Time Frame: End of study ]
  3. Progression-free survival. [ Time Frame: End of study ]
  4. Quality of life. [ Time Frame: End of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376103


Locations
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United States, Tennessee
Methodist University Hospital
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Methodist Healthcare
Investigators
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Principal Investigator: Allen K Sills, MD Methodist University Hospital
More Information
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Responsible Party: Allen Sills, MD, Methodist Healthcare
ClinicalTrials.gov Identifier: NCT00376103    
Other Study ID Numbers: MHIRB 2006-032
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009
Keywords provided by Methodist Healthcare:
Brain Tumor
GBM
Glioblastoma Multiforme
Glioblastoma
 Brachytherapy
Temozolomide
Temodar
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents