PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
NCT ID: NCT01402063
Last Updated: 2020-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2011-09-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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radiation plus PPX(CT2103
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103)
XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
radiation + Temozolomide
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide
XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
Interventions
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PPX (CT2103)
XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
Temozolomide
XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
Eligibility Criteria
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Inclusion Criteria
* GBM must have unmethylated MGMT as determined by central laboratory
* Diagnosis of GBM must be made by biopsy or surgical excision, either partial or complete; as long as there is sufficient tissue to determine MGMT status
* No prior chemotherapy or radiation for brain tumor
* Must be able to tolerate brain MRIs.
\*A diagnostic contrast-enhanced MRI must be performed postoperatively within 42 days prior to study registration.
* KPS \>60.
* Age \> 18
* Life expectancy of at least 3 months.
* Absolute neutrophil count \> 1500/mm3, Platelets \> 100,000/mm,
* Creatinine \< 2 x ULN
* ALT or AST \< 3 x upper limit of normal (ULN) and total bilirubin \< 1.5x ULN.
* Patients with a prior history of low grade glioma who did not receive prior radiation or chemotherapy with transformation to grade IV brain tumor are eligible.
* Women must be non-lactating, and surgically sterile, post-menopausal or have a negative serum pregnancy test and agree to use adequate birth control. Males must agree to use adequate birth control.
* Voluntary, signed informed consent.
Exclusion Criteria
* No other active invasive malignancy unless disease free for at least 3 years.
* Prior temozolomide or PPX.
* Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
* Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
* No diffuse leptomeningeal disease, or gliomatosis cerebri.
* Use of any other experimental chemotherapy drug within the 60 days prior to randomization and during the trial. (Use of a non-chemotherapy investigational agent must be approved by the Brown University Oncology Group)
18 Years
ALL
No
Sponsors
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Rhode Island Hospital
OTHER
Milton S. Hershey Medical Center
OTHER
University of Washington
OTHER
University of Massachusetts, Worcester
OTHER
MaineHealth
OTHER
University of California, San Diego
OTHER
Thomas Jefferson University
OTHER
Brown University
OTHER
Responsible Party
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howard safran
Principal Investigator
Principal Investigators
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Howard Safran, MD
Role: PRINCIPAL_INVESTIGATOR
BrUOG
Locations
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UCSD Cancer Center
La Jolla, California, United States
Maine Medical Center
Scarborough, Maine, United States
UMASS Medical Center Cancer Center
Worcester, Massachusetts, United States
SUNY Medical Center
Syracuse, New York, United States
PSU
Hershey, Pennsylvania, United States
Thomas Jefferson University Cancer Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
UT Southwestern Cancer Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Jeyapalan S, Boxerman J, Donahue J, Goldman M, Kinsella T, Dipetrillo T, Evans D, Elinzano H, Constantinou M, Stopa E, Puthawala Y, Cielo D, Santaniello A, Oyelese A, Mantripragada K, Rosati K, Isdale D, Safran H; Brown University Oncology Group Study. Paclitaxel poliglumex, temozolomide, and radiation for newly diagnosed high-grade glioma: a Brown University Oncology Group Study. Am J Clin Oncol. 2014 Oct;37(5):444-9. doi: 10.1097/COC.0b013e31827de92b.
Other Identifiers
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BrUOG 244
Identifier Type: -
Identifier Source: org_study_id
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