Status:
COMPLETED
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
Lead Sponsor:
Brown University
Collaborating Sponsors:
Rhode Island Hospital
Milton S. Hershey Medical Center
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.
Detailed Description
To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study whether PPX/RT i...
Eligibility Criteria
Inclusion
- Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV)
- 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
- Acute infection or other medical condition that would impair study treatment
- 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)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01402063
Start Date
September 1 2011
End Date
June 1 2015
Last Update
February 17 2020
Active Locations (9)
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1
UCSD Cancer Center
La Jolla, California, United States, 92093
2
Maine Medical Center
Scarborough, Maine, United States, 04074
3
UMASS Medical Center Cancer Center
Worcester, Massachusetts, United States, 01605
4
SUNY Medical Center
Syracuse, New York, United States, 13210