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Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

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ClinicalTrials.gov Identifier: NCT00200161
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Schering-Plough
Columbia University
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Results First Submitted Date January 10, 2018
Results First Posted Date March 7, 2018
Last Update Posted Date March 7, 2018
Study Start Date  ICMJE August 9, 2005
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid. [ Time Frame: until death or date of last follow up, an average of 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To determine the overall survival of patients with newly diagnosed glioblastoma multiforme treated with concurrent temozolomide and radiotherapy followed by dose dense or metronomic dosing of temozolomide and maintenance cis-retinoic acid.
Change History Complete list of historical versions of study NCT00200161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Progression Free Survival at 6 Months [ Time Frame: 6 months ]
  • Prognostic Impact of Methylated MGMT Status. [ Time Frame: through study completion, an average of 1 year ]
    MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR.
  • To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes. [ Time Frame: through study completion, an average of 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Progression free survival
  • To evaluate the prognostic impact of methylated MGMT status.
  • To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Official Title  ICMJE A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas
Brief Summary Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.
Detailed Description

This is a randomized phase II study that will test two different adjuvant temozolomide regimens in patients with newly diagnosed glioblastoma multiforme. The goal of this study is to identify a regimen that would be appropriate to bring to a phase III trial and compare to the standard dosing regimen of temozolomide recently reported by Stupp et al. in the New England Journal of Medicine. Secondary goals of this study include: prospective analysis of the prognostic impact of MGMT status and generation of preliminary data regarding this treatment strategy for other types of malignant glioma.

The decision regarding which treatment patients receive is made randomly. Neither them or their doctor can select which treatment the patient will receive. There is reason to believe that both of these doses may benefit treating your brain tumor. After 6 months of chemotherapy, and assuming the brain tumor has not shown any sign of growth, they will begin receiving cis-retinoic acid. Cis retinoic acid has been shown in one study to possibly prevent or delay tumor recurrence.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma
  • Gliomas
Intervention  ICMJE
  • Drug: Temozolomide
    Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
  • Drug: Temozolomide
    Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
Study Arms
  • Active Comparator: Metronomic Therapy Cohort
    Concurrent temozolomide and radiotherapy plus lose dose of temozolomide
    Intervention: Drug: Temozolomide
  • Experimental: Dose-Dense Therapy Cohort
    Concurrent temozolomide and radiotherapy plus high dose of temozolomide
    Intervention: Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2018)
127
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
98
Actual Study Completion Date May 4, 2017
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologic evidence of a malignant glioma.
  • Tissue block or unstained slides must be available for MGMT analysis.
  • Age 18-70
  • KPS > 50
  • Granulocyte count >1.5 X 109/L
  • Platelet count >99 X 109/L
  • SGOT < 2.5X upper limit of normal (ULN).
  • Serum creatinine < 2X ULN.
  • Bilirubin < 2X ULN.
  • All patients must sign written informed consent.

Exclusion Criteria:

  • Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
  • Any prior experimental therapy for glioma.
  • Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
  • Serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment.
  • Pregnant or breast feeding women.
  • Refusal to use effective contraception.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200161
Other Study ID Numbers  ICMJE 05-079
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Schering-Plough
  • Columbia University
  • Dana-Farber Cancer Institute
Investigators  ICMJE
Principal Investigator: Lisa DeAngelis, M.D Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2016

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