Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME
5 other identifiers
interventional
118
1 country
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2006
Longer than P75 for phase_1
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2006
CompletedFirst Submitted
Initial submission to the registry
March 21, 2006
CompletedFirst Posted
Study publicly available on registry
March 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2011
CompletedResults Posted
Study results publicly available
May 17, 2013
CompletedMarch 5, 2018
February 1, 2018
5 years
March 21, 2006
March 5, 2013
February 2, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose of MGd (Phase I)
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
From start of radiation therapy to 90 days,
Median Overall Survival (Phase II)
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.
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
Secondary Outcomes (1)
Progression-free Survival (Phase II)
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.
Study Arms (4)
Phase I: MGd 3 mg/kg
EXPERIMENTALPatients 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.
Phase I: MGd 4 mg/kg
EXPERIMENTALPatients 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.
Phase I: MGd 5 mg/kg
EXPERIMENTALPatients 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.
Phase II: MGd 5 mg/kg
ACTIVE COMPARATORPatients 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.
Interventions
Undergo radiotherapy
Given IV
Given orally
Eligibility Criteria
You may qualify if:
- 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)
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Radiation Therapy Oncology Groupcollaborator
Study Sites (106)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, 85260, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Saint Rose Hospital
Hayward, California, 94545, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
El Camino Hospital
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Denver Veterans Administration Medical Center
Denver, Colorado, 80220, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Franciscan Saint Margaret Health-Hammond Campus
Hammond, Indiana, 46320, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Mercy Hospital-Joplin
Joplin, Missouri, 64804, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
John F Kennedy Medical Center
Edison, New Jersey, 08818, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
Rex Cancer Center
Raleigh, North Carolina, 27607, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096, United States
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, 78209, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University Hospital
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Intermountain Health Care
Salt Lake City, Utah, 84103, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 25832688RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
David Brachman
Radiation Therapy Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2006
First Posted
March 22, 2006
Study Start
February 9, 2006
Primary Completion
February 16, 2011
Study Completion
March 15, 2011
Last Updated
March 5, 2018
Results First Posted
May 17, 2013
Record last verified: 2018-02