Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
NCT ID: NCT00305864
Last Updated: 2018-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
118 participants
INTERVENTIONAL
2006-02-09
2011-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Motexafin Gadolinium
Given IV
Temozolomide
Given orally
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.
3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Motexafin Gadolinium
Given IV
Temozolomide
Given orally
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.
3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Motexafin Gadolinium
Given IV
Temozolomide
Given orally
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.
3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Motexafin Gadolinium
Given IV
Temozolomide
Given orally
Interventions
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3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Motexafin Gadolinium
Given IV
Temozolomide
Given orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Radiation Therapy Oncology Group
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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David Brachman
Role: PRINCIPAL_INVESTIGATOR
Radiation Therapy Oncology Group
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Saint Rose Hospital
Hayward, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
El Camino Hospital
Mountain View, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Denver Veterans Administration Medical Center
Denver, Colorado, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Franciscan Saint Margaret Health-Hammond Campus
Hammond, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
McLaren Cancer Institute-Flint
Flint, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Mercy Hospital-Joplin
Joplin, Missouri, United States
CHI Health Good Samaritan
Kearney, Nebraska, United States
John F Kennedy Medical Center
Edison, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States
Rex Cancer Center
Raleigh, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, United States
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States
University Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Intermountain Health Care
Salt Lake City, Utah, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Brachman DG, Pugh SL, Ashby LS, Thomas TA, Dunbar EM, Narayan S, Robins HI, Bovi JA, Rockhill JK, Won M, Curran WP. Phase 1/2 trials of Temozolomide, Motexafin Gadolinium, and 60-Gy fractionated radiation for newly diagnosed supratentorial glioblastoma multiforme: final results of RTOG 0513. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):961-7. doi: 10.1016/j.ijrobp.2014.12.050.
Other Identifiers
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NCI-2009-01092
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000467802
Identifier Type: -
Identifier Source: secondary_id
RTOG 0513
Identifier Type: OTHER
Identifier Source: secondary_id
RTOG-0513
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-01092
Identifier Type: -
Identifier Source: org_study_id
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