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Memantine for Recurrent Glioblastoma

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: NCT01260467
Recruitment Status : Terminated
First Posted : December 15, 2010
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Nimish Mohile, University of Rochester

Tracking Information
First Submitted Date  ICMJE December 10, 2010
First Posted Date  ICMJE December 15, 2010
Results First Submitted Date  ICMJE June 19, 2015
Results First Posted Date  ICMJE December 10, 2015
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
  • Overall Survival [ Time Frame: 30 months ]
  • 6 Month Progression-free Survival [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01260467 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
Number of Participants With Adverse Events [ Time Frame: 24 months ]
This study will look at the number of participants who develop adverse events or side effects thought to be related to the memantine.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
Number of Participants wih Adverse Events [ Time Frame: 24 months ]
This study will look at the number of particpants who develop adverse events or side effects thought to be related to the memantine.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Memantine for Recurrent Glioblastoma
Official Title  ICMJE A Phase II Study of Memantine in the Treatment of Recurrent Glioblastoma
Brief Summary The purpose of this study is to determine if a medication called memantine is effective in treating glioblastoma. Memantine targets a specific receptor, called a glutamate receptor, which is thought to be involved in the growth of brain tumors. It has previously been studied for other types of conditions, such as Alzheimer's disease, but it has not yet been evaluated in the treatment of brain tumors. The investigators will also be determining how common it is for patients with brain tumors to have side effects to memantine. Memantine will be taken by mouth twice a day.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: memantine
10 milligrams orally twice a day
Other Name: Namenda
Study Arms  ICMJE Experimental: memantine arm
Intervention: Drug: memantine
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 2, 2014)
4
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2010)
33
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically proven World Health Organization (WHO) grade IV gliomas. Patients will be eligible if the original histology was a grade II or grade III glioma as long as a subsequent histological diagnosis of a grade IV glioma is confirmed.
  • Patients must have shown unequivocal radiographic evidence for tumor progression by magnetic resonance imaging (MRI) scan. A scan should be performed within 10 days prior to registration and on a steroid dose that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration a new baseline MRI is required.
  • Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery (including gamma-knife or cyber-knife) must have confirmation of true progressive disease rather than radiation necrosis based upon either positron emission tomography (PET) or Thallium scanning, magnetic resonance spectroscopy (MRS), magnetic resonance perfusion, or surgical documentation of disease. The decision of which modality to use to make this confirmation will be at the discretion of the investigator.
  • All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
  • Age greater than 18 years old, and with a life expectancy greater than 8 weeks.
  • Karnofsky Performance Status greater or equal to 60
  • Patients must have an interval of at least 28 days from any investigational agent or from prior cytotoxic therapy, 6 weeks from prior nitrosureas, 3 weeks from procarbazine and 2 weeks from vincristine.
  • Patients must have failed prior radiotherapy and must have an interval of greater than 42 days from completion of initial radiation therapy to study entry or 28 days since radiation therapy used for recurrent tumor.
  • Since memantine is not associated with myelosuppression, patients with persistent effects on bone marrow function from prior cytotoxic chemotherapies will be eligible as long as: white blood cells > 1,000/µl, absolute neutrophil count > 500/mm3, platelet count of > 50,000/mm3, and hemoglobin > 8 gm/dl). Patients must have adequate liver function and adequate renal function before starting therapy. These tests must be performed within 2 weeks prior to treatment initiation. Eligibility level for hemoglobin may be reached by transfusion.
  • Patients must have a calculated creatinine clearance > 30 milliliters/minute.

Exclusion Criteria:

  • Patients who are within 3 months of treatment with radiation and concurrent temozolomide will not be eligible unless there are new enhancing abnormalities outside the high dose radiation fields (i.e beyond the 80% isodose line) or surgical demonstration of active tumor.
  • Patients must not be pregnant and must agree to practice adequate contraception. Women of childbearing potential must have a negative pregnancy test documented within 7 days prior to registration. Women must not be breastfeeding.
  • Patients with a history of other cancer (except non-melanoma skin cancer or cancer of the cervix), unless in complete remission for at least 3 years are ineligible.
  • Patients must not have any significant medical illnesses or other history that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
  • Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
  • Patients must not have prior or concurrent use of memantine or treatment with other N-methyl D-asparate (NMDA) receptor blocking therapies.
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT01260467
Other Study ID Numbers  ICMJE RSRB34285
054835-002 ( Other Grant/Funding Number: American Society of Clinical Oncology )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nimish Mohile, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nimish Mohile, MD University of Rochester
PRS Account University of Rochester
Verification Date November 2015

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