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Validation of the Role of Levetiracetam for Newly Diagnosed GBM Patients

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ClinicalTrials.gov Identifier: NCT02815410
Recruitment Status : Not yet recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Chae-Yong Kim, Seoul National University Hospital

Brief Summary:
Prospective, open-labeled, multicenter cohort trial for validation of the role of levetiracetam as a sensitizer of temozolomide in the treatment of newly diagnosed glioblastoma patients.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: levetiracetam Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prospective Trial for Validation of the Role of Levetiracetam as a Sensitizer of Temozolomide in the Treatment of Newly Diagnosed Glioblastoma Patients
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Levetiracetam
Newly diagnosed histologically proven supratentorial glioblastoma patients received levetiracetam during and after their CCRT
Drug: levetiracetam
Patients in this group are with newly diagnosed glioblastoma patients who are supposed to be treated with concurrent chemoradiotherapy (CCRT) and adjuvant chemotherapy with temozolomide (TMZ). Patients ( intervention Group) will be given levetiracetam (LEV) from the beginning of treatment till after the adjuvant chemotherapy with TMZ is over.
Other Name: keppra®




Primary Outcome Measures :
  1. 6 months Progression free survival [ Time Frame: from the first operation to following 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: from the first operation to following 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV). The histological diagnosis must be obtained from a neurosurgical resection or biopsy of a tumor including an open biopsy or stereotactic biopsy.
  2. Age 20 -76 years
  3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
  4. Meets 1 of the following RPA classifications:

    4-1. Class III (Age <50 years and ECOG PS 0) 4-2. Class IV (meeting one of the following criteria: a) Age <50 years and ECOG PS 1 or b) Age ≥50 years, underwent prior partial or total tumor resection, MMSE ≥27) 4-3. Class V (meeting one of the following criteria: a) Age ≥50 years and underwent prior partial or total tumor resection, MMSE <27 or b) Age ≥50 years and underwent prior tumor biopsy only)

  5. Adequate hematologic, renal, and hepatic function:

    ANC > 1,500/uL Platelet > 100,000/uL Serum creatinine <1.7mg/dL Bilirubin level < 2.0 mg/dL AST/ALT < 2.5 x upper limit of normal range of each institution

  6. Written informed consent

Exclusion Criteria:

  1. Prior chemotherapy within last 5 years
  2. Prior radiotherapy of the head and neck area
  3. Receiving concurrent investigational agents or has received an investigational agent within 30 days prior to randomization
  4. Planned surgery for other diseases (e.g. dental extraction)
  5. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for 5 years are eligible for this study
  6. Pregnant or lactating women
  7. Subject who disagree to follow acceptable methods of contraception
  8. Concurrent illness including unstable heart disease despite appropriate treatment, history of myocardial infarction within 6 months, serious neurological or psychological disease, and uncontrolled infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815410


Contacts
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Contact: Chae-Yong Kim, PhD +82-31-787-7165 chaeyong@snu.ac.kr
Contact: Eun-Jin Choi +82-10-3459-1198 r0415@snubh.org

Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chae-Yong Kim, PhD Seoul National University Bundang Hospital

Publications:
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Responsible Party: Chae-Yong Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02815410     History of Changes
Other Study ID Numbers: cykim
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chae-Yong Kim, Seoul National University Hospital:
Glioblastoma Multiforme
Levetiracetam
Temozolomide
Survival outcome
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Levetiracetam
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anticonvulsants
Nootropic Agents