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Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00498927
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Weill Medical College of Cornell University
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE July 10, 2007
First Posted Date  ICMJE July 11, 2007
Results First Submitted Date  ICMJE October 5, 2015
Results First Posted Date  ICMJE February 29, 2016
Last Update Posted Date February 29, 2016
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Progression-free Survival (PFS) Rate at 6 Months [ Time Frame: at 6 months ]
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
Progression-free Survival (PFS) Rate at 6 Months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Overall Survival [ Time Frame: 2 years ]
All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
  • Overall Survival
  • Overall response rate
  • PFS
  • Toxicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Official Title  ICMJE A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

Detailed Description

OBJECTIVES:

Primary

  • Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide.

Secondary

  • Determine the overall survival of patients treated with this drug.

OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: temozolomide
  • Genetic: protein expression analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunoenzyme technique
Study Arms  ICMJE Experimental: Temozolomide
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
Interventions:
  • Drug: temozolomide
  • Genetic: protein expression analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunoenzyme technique
Publications * Omuro A, Chan TA, Abrey LE, Khasraw M, Reiner AS, Kaley TJ, Deangelis LM, Lassman AB, Nolan CP, Gavrilovic IT, Hormigo A, Salvant C, Heguy A, Kaufman A, Huse JT, Panageas KS, Hottinger AF, Mellinghoff I. Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma. Neuro Oncol. 2013 Feb;15(2):242-50. doi: 10.1093/neuonc/nos295. Epub 2012 Dec 14.

*   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: July 10, 2007)
47
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Pathologically diagnosed glioblastoma multiforme or other malignant glioma

    • Recurrent disease
  • Must have received prior temozolomide

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • SGOT ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 2 times ULN
  • Bilirubin ≤ 2 times ULN
  • No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin
  • No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment
  • No medical condition that precludes swallowing pills
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT00498927
Other Study ID Numbers  ICMJE 07-064
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07064
SPRI-PO5096
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Weill Medical College of Cornell University
  • Schering-Plough
Investigators  ICMJE
Principal Investigator: Antonio Omuro, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Thomas Kaley, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date February 2016

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