Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

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: NCT00305864
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : May 17, 2013
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Motexafin gadolinium may help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with temozolomide and radition therapy may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Radiation: 3-Dimensional Conformal Radiation Therapy Drug: Motexafin Gadolinium Drug: Temozolomide Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of motexafin gadolinium (MGd) when given concurrently with temozolomide and radiotherapy in patients with newly diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma.

II. Estimate the overall survival of patients treated with concurrent radiotherapy, temozolomide, and MGd followed by post-radiation temozolomide.

III. Determine the short- and long-term adverse effects in patients treated with this treatment.

IV. Estimate the progression-free survival of patients with newly diagnosed supratentorial GBM or gliosarcoma treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (MGd).

PHASE I: Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-7 patients receive escalating doses of MGd until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which no more than 6 eligible patients experience dose-limiting toxicity.

PHASE II: Patients undergo radiotherapy and receive temozolomide as in phase I. Patients also receive MGd as in phase I at the MTD determined in phase I.

After completion of study treatment, patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME
Actual Study Start Date : February 9, 2006
Actual Primary Completion Date : February 16, 2011
Actual Study Completion Date : March 15, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase I: MGd 3 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy

Drug: Motexafin Gadolinium
Given IV
Other Names:
  • API-GP3
  • gadolinium texaphyrin
  • Gd (III) Texaphryin
  • Gd-Tex
  • PCI-0120
  • Xcytrin

Drug: Temozolomide
Given orally
Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac

Experimental: Phase I: MGd 4 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40.Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy

Drug: Motexafin Gadolinium
Given IV
Other Names:
  • API-GP3
  • gadolinium texaphyrin
  • Gd (III) Texaphryin
  • Gd-Tex
  • PCI-0120
  • Xcytrin

Drug: Temozolomide
Given orally
Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac

Experimental: Phase I: MGd 5 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy

Drug: Motexafin Gadolinium
Given IV
Other Names:
  • API-GP3
  • gadolinium texaphyrin
  • Gd (III) Texaphryin
  • Gd-Tex
  • PCI-0120
  • Xcytrin

Drug: Temozolomide
Given orally
Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac

Active Comparator: Phase II: MGd 5 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy

Drug: Motexafin Gadolinium
Given IV
Other Names:
  • API-GP3
  • gadolinium texaphyrin
  • Gd (III) Texaphryin
  • Gd-Tex
  • PCI-0120
  • Xcytrin

Drug: Temozolomide
Given orally
Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac




Primary Outcome Measures :
  1. Maximum Tolerated Dose of MGd (Phase I) [ Time Frame: From start of radiation therapy to 90 days, ]

    Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the maximum tolerated dose (MTD). The MTD would be used for the Phase II arm.

    Rating scale: 0 = not the MTD, 1 = MTD


  2. Median Overall Survival (Phase II) [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months ]
    Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.


Secondary Outcome Measures :
  1. Progression-free Survival (Phase II) [ Time Frame: From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months. ]
    Progression will be defined as a > 25% increase in tumor area. Progression-free survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma

    • Newly diagnosed by surgical biopsy or excision within the past 5 weeks
  • Supratentorial location, as determined by the following:

    • Contrast-enhanced MRI performed preoperatively
    • MRI performed postoperatively within 28 days prior to study entry (preferably within 72 hours of surgery)
    • Postoperative scan not required if diagnosed by stereotactic biopsy and pre-operative MRI was performed
  • No gliomas graded < GBM
  • No recurrent malignant gliomas
  • No tumor foci detected below the tentorium or beyond the cranial vault
  • No multifocal disease or leptomeningeal spread
  • Zubrod performance status 0-1
  • Neurologic function status 0-2
  • Absolute neutrophil count ≥ 1,800 cells/mm^3
  • Platelet count ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 8 g/dL (transfusion allowed)
  • BUN ≤ 25 mg/dL
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 mg/dL
  • ALT or AST ≤ 2 times upper limit of normal
  • Fertile patients must use effective contraception during and for 2 months after completion of study treatment
  • Negative pregnancy test
  • Not pregnant or nursing
  • No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ? 3 years
  • No severe, active comorbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at study entry
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to study entry
    • Coagulation defects
    • Known AIDS
  • No prior allergic reaction to the study drugs
  • No history of porphyria or G6PD deficiency
  • No allergy to gadolinium or contraindications to MRI
  • No other concurrent chemotherapy
  • Recovered from effects of surgery or postoperative infection and other complications
  • No prior systemic chemotherapy, including polifeprosan 20 with carmustine implant (Gliadel wafer), for the current GBM

    • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would result in overlap of radiation therapy fields
  • No prophylactic filgrastim (G-CSF) during the first course of study treatment
  • No concurrent sargramostim (GM-CSF)

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): NCT00305864


Locations
Hide Hide 106 study locations
Layout table for location information
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Arizona
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
United States, California
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
Bay Area Breast Surgeons Inc
Emeryville, California, United States, 94608
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Saint Rose Hospital
Hayward, California, United States, 94545
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
El Camino Hospital
Mountain View, California, United States, 94040
Highland General Hospital
Oakland, California, United States, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Tumor Institute
Oakland, California, United States, 94609
Hematology and Oncology Associates-Oakland
Oakland, California, United States, 94609
Tom K Lee Inc
Oakland, California, United States, 94609
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
United States, Colorado
Denver Veterans Administration Medical Center
Denver, Colorado, United States, 80220
United States, Florida
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States, 32209
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Heartland Cancer Research NCORP
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
Franciscan Saint Margaret Health-Hammond Campus
Hammond, Indiana, United States, 46320
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
McLaren Cancer Institute-Flint
Flint, Michigan, United States, 48532
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Lake Huron Medical Center
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Missouri
Mercy Hospital-Joplin
Joplin, Missouri, United States, 64804
United States, Nebraska
CHI Health Good Samaritan
Kearney, Nebraska, United States, 68847
United States, New Jersey
John F Kennedy Medical Center
Edison, New Jersey, United States, 08818
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
United States, North Carolina
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States, 27607
Rex Cancer Center
Raleigh, North Carolina, United States, 27607
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Main Line Health NCORP
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, United States, 78209
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
University Hospital
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, United States, 84003
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Intermountain Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Intermountain Health Care
Salt Lake City, Utah, United States, 84103
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Investigators
Layout table for investigator information
Principal Investigator: David Brachman Radiation Therapy Oncology Group

Publications of Results:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00305864    
Other Study ID Numbers: NCI-2009-01092
NCI-2009-01092 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000467802
RTOG 0513 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0513 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2006    Key Record Dates
Results First Posted: May 17, 2013
Last Update Posted: March 5, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Motexafin gadolinium
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents