MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

This study has been terminated.
(Funding ended)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth R. Gerstner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00756106
First received: September 18, 2008
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation therapy and chemotherapy work in killing tumor cells and allow doctors to plan better treatment.

PURPOSE: This clinical trial is studying MRI scans to see how well they evaluate the effects of radiation therapy and chemotherapy in patients with newly diagnosed glioblastoma multiforme or anaplastic glioma.


Condition Intervention
Brain and Central Nervous System Tumors
Drug: temozolomide
Other: imaging biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Assessment of the Early and Late Effects of Radiation and Chemotherapy on Glioblastoma Using Multiple MRI Techniques

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Relative cerebral blood volume/flow, mean transit time, and mean vessel diameter as measured by perfusion-weighted MRI before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
  • Permeability-surface area product before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
  • Full water self-diffusion tensor before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
  • Tensor fractional anisotropy before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
  • Relative regional concentrations of choline, N-acetyl-asparate, and myoinositol as measured by magnetic resonance spectroscopy before, during, and after chemoradiotherapy to interrogate cell membrane turnover, neuronal integrity, and glial reactions [ Time Frame: months ] [ Designated as safety issue: No ]
  • Affects of a short period of 100% oxygen inhalation on imaging of tumor and surrounding tissue regions of interest, specifically cerebral blood volume changes in each area as compared to room air [ Time Frame: months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between imaging changes, molecular markers, and clinical outcome [ Time Frame: months ] [ Designated as safety issue: No ]
  • Correlation between blood and urine biomarkers and tumor expression of these markers [ Time Frame: months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2008
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: temozolomide
    chemotherapy
    Other: imaging biomarker analysis
    MRI
Detailed Description:

OBJECTIVES:

Primary

  • To quantitatively compare the relative cerebral blood volume/flow, mean transit time, and mean vessel diameter as measured by perfusion-weighted MRI before, during, and after chemoradiotherapy in patients with newly diagnosed glioblastoma multiforme.
  • To measure the permeability-surface area product on a voxel-by-voxel basis before, during, and after chemoradiotherapy in these patients.
  • To measure the full water self-diffusion tensor on a voxel-by-voxel basis before, during, and after chemoradiotherapy in these patients.
  • To compare the tensor fractional anisotropy before, during, and after chemoradiotherapy in these patients.
  • To compare the relative regional concentrations of choline, N-acetyl-asparate, and myoinositol as measured by magnetic resonance spectroscopy before, during, and after chemoradiotherapy to interrogate cell membrane turnover, neuronal integrity, and glial reactions.
  • To test the affects of a short period of 100% oxygen inhalation on imaging of tumor and surrounding tissue regions of interest, specifically cerebral blood volume changes in each area as compared to room air.

Secondary

  • To collect blood and urine samples for correlation analysis between imaging changes, molecular markers (including genetic markers), and clinical outcome of glioblastoma multiforme (phenotypic information).
  • To correlate blood and urine biomarkers and blood genetic markers with tumor expression of these markers.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients also receive oral temozolomide once daily 7 days a week during radiotherapy. After completion of chemoradiotherapy, patients receive oral temozolomide once daily for 5 days. Treatment with temozolomide repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo MRI, including perfusion- and diffusion-weighted MRI, diffusion tensor imaging, and magnetic resonance spectroscopy prior to initiation of chemoradiotherapy, once weekly during chemoradiotherapy, and then monthly until tumor progression or until completion of 6 courses of post chemoradiotherapy.

After completion of study treatment, patients are followed annually.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Newly diagnosed GBM

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed anaplastic glioma (WHO grade III) or glioblastoma multiforme (WHO grade IV)
  • Measurable disease

    • Residual tumor size after surgery ≥ 1 cm in one dimension
  • Planning to undergo standard chemoradiotherapy with temozolomide

PATIENT CHARACTERISTICS:

  • Glomerular filtration rate ≥ 60 mL/min
  • Mini Mental Status Exam score > 15
  • Sufficiently competent to give informed consent
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
  • No contraindication to MRI or to use of the contrast agent gadolinium, including any of the following:

    • Claustrophobia
    • Metallic objects or implanted medical devices (e.g., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
    • Sickle cell disease
    • Renal failure
    • High risk for kidney disease (e.g., age > 60 years, diabetes, or history of systemic lupus erythematosus or multiple myeloma)
  • No known history of chronic obstructive pulmonary disease or emphysema
  • No other co-existing condition that, in the judgement of the investigator, may increase risk to the patient

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Non-VEGF investigational agent allowed
  • No concurrent chemotherapy (other than temozolomide)
  • No concurrent electron, proton, particle, or implant radiotherapy
  • No concurrent stereotactic radiosurgery
  • No concurrent anti-VEGF anti-tumor agents
  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: NCT00756106

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elizabeth Gerstner, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Elizabeth R. Gerstner, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00756106     History of Changes
Other Study ID Numbers: CDR0000600751, MGH-07-292
Study First Received: September 18, 2008
Last Updated: February 6, 2014
Health Authority: United States: NCI

Keywords provided by Massachusetts General Hospital:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult mixed glioma

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

ClinicalTrials.gov processed this record on August 18, 2014