Clinical trial NCT01402063: PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
Official title: PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Brain Tumors
Glioblastoma Multiforme
GBM
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: Milton S. Hershey Medical Center
name: University of Washington
name: University of Massachusetts, Worcester
name: MaineHealth
name: University of California, San Diego
name: Thomas Jefferson University
First posted: 2011-07-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 improves overall survival as compared to temozolomide /RT for patients with GBM without MGMT methylation to facilitate planning a phase III study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation
timeFrame: Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Cancer Center
state: California
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Worcester
country: United States
facility: UMASS Medical Center Cancer Center
state: Massachusetts
city: Syracuse
country: United States
facility: SUNY Medical Center
state: New York
city: Hershey
country: United States
facility: PSU
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: UT Southwestern Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: BrUOG
name: Howard Safran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.