Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

This study has been completed.
Sponsor:
Collaborators:
Rhode Island Hospital
Milton S. Hershey Medical Center
University of Washington
University of Massachusetts, Worcester
Maine Medical Center
University of California, San Diego
Thomas Jefferson University
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01402063
First received: July 8, 2011
Last updated: July 8, 2015
Last verified: July 2015

July 8, 2011
July 8, 2015
September 2011
April 2014   (final data collection date for primary outcome measure)
Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation [ Time Frame: 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. ] [ Designated as safety issue: No ]

MRI response evaluated by RANO criteria

  • Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response.
  • Partial Response (PR): Decrease of > 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan.
  • Progression (P): A > 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT.
evaluate the toxicities of PPX/RT at years 1 and 2 of the trial [ Time Frame: At years 1 and 2 ] [ Designated as safety issue: Yes ]
Patients will be evaluated throughout their treatment however a cumulative evaluation will be conducted at years 1 and 2 of the trial
Complete list of historical versions of study NCT01402063 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • Drug: 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.
  • Drug: 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
  • Experimental: 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

    Intervention: Drug: PPX (CT2103)
  • Active Comparator: 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

    Intervention: Drug: Temozolomide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2015
April 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01402063
BrUOG 244
Yes
Not Provided
Not Provided
howard safran, Brown University
Brown University
  • Rhode Island Hospital
  • Milton S. Hershey Medical Center
  • University of Washington
  • University of Massachusetts, Worcester
  • Maine Medical Center
  • University of California, San Diego
  • Thomas Jefferson University
Principal Investigator: Howard Safran, MD BrUOG
Brown University
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP