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Trial record 7 of 1115 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma
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Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma (METT)

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ClinicalTrials.gov Identifier: NCT03243851
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Saint Vincent's Hospital, Korea
Incheon St.Mary's Hospital
National Cancer Center, Korea
Konkuk University Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Seoul National University Hospital
Asan Medical Center
Ajou University School of Medicine
Severance Hospital
Chonnam National University Hospital
Seoul St. Mary's Hospital
Information provided by (Responsible Party):
Yong-Kil Hong, Seoul St. Mary's Hospital

Study Description
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Brief Summary:
A phase 2 clinical trial for the efficacy and safety of low dose Temozolomide plus metformin as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with recurrent or refractory Glioblastoma

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Temozolomide+Metformin Drug: Temozolomide+Placebo Phase 2

Detailed Description:

Studies will investigate the efficacy and safety of low dose Temozolomide with Metformin or placebo for the patients with recurrent or refractory Glioblastoma.

The dosage of the Metformin will follow the domestically permitted dose to minimize side effects.

The patients will be allocated randomly to arm 1(experimental) and arm 2(placebo controlled) and administered the investigational products for up to 6 cycle. Each cycle consists of 4 weeks.

After 6 cycle(24 weeks), the patients will be checked progression and survival every 24 weeks up to 96 weeks.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1 : Low dose temozolomide+metformin Arm 2 : Low dose temozolomide+placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Low Dose Temozolomide Plus Metformin as Combination Chemotherapy Compared With Low Dose Temozolomide Plus Placebo in Patient With Recurrent or Refractory Glioblastoma
Actual Study Start Date : November 21, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Temozolomide+metformin

Temozolomide :

1 cycle of 4 weeks with daily dose 50mg/m2(BSA: Body Surface Area) up to 6 cycles for 24 weeks

Metformin :

  1. 1st cycle (4 weeks)

    • 1 week(1st~7th day) = 1,000mg/day
    • 1 week(8th~14th day) = 1,500mg/day
    • 2 weeks(15th ~28th day) = 2,000mg/day
  2. 2nd to 6th cycle (20 weeks) = 2,000mg/day
 Drug: Temozolomide+Metformin
Low dose temozolomide+metformin for 24 weeks
Placebo Comparator: Temozolomide+placebo

Temozolomide :

1 cycle of 4 weeks with daily dose 50mg/m2(BSA: Body Surface Area) up to 6 cycles for 24 weeks

Placebo:

  1. 1st cycle (4 weeks)

    • 1 week(1st~7th day) = 1,000mg/day
    • 1 week(8th~14th day) = 1,500mg/day
    • 2 weeks(15th~28th day) = 2,000mg/day
  2. 2nd to 6th cycle (20 weeks) = 2,000mg/day
 Drug: Temozolomide+Placebo
Low dose temozolomide+placebo for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of progression-free survival obtained from progression-free survival curve [ Time Frame: 24 weeks ]
    Comparison of progression-free survival obtained from progression-free survival curve


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 4 weeks, 8 weeks, 16 weeks, 24 weeks thereafter every 24 weeks up to 96 weeks ]
    Tumor Response Rate

  2. Tumor control probability [ Time Frame: 4 weeks, 8 weeks, 16 weeks, 24 weeks thereafter every 24 weeks up to 96 weeks ]
    Tumor control probability

  3. 6 month progression free survival [ Time Frame: 24 weeks ]
    6 month progression free survival

  4. 6 month overall survival [ Time Frame: 24 weeks ]
    6 month overall survival

  5. Assessment of the quality of life of cancer patients [ Time Frame: 4 weeks, 8 weeks, 16 weeks, 24 weeks ]
    EORTC QLQ-C30 and EORTC QLQ-BN20


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Progressive or recurrent Glioblastoma conformed by histopathological or radiological diagnosis. Progressive or recurrent Glioblastoma during or after standard therapy (Temozolomide after Temozolomide and radiation therapy; Stupp regimen) after histopathological diagnosis of Glioblastoma Recurrence or progression is diagnosed according to histopathological diagnosis or revised RANO(Response Assessment in Neuro-Oncology) criteria c
  2. Karnofsky performance status(KPS) ≥ 60%
  3. Age ≥ 19 years old
  4. At least 4 weeks after operation or chemotherapy

  5. Normal in hematological finding, liver and kidney function

    • Hematology ANC > 1.500/mm³, Platelet > 100,000/mm³, WBC > 3×10^9/L, Hemoglobin > 9g/dL
    • Liver function Total Bilirubin level ≤ 1.5×ULN(in case of isolated hyperbilirubinemia ≤2.5 x ULN) AST / ALT < 2.5×ULN
    • Renal function Serum creatinine ≤ 1.5mg/dL
  6. Be informed of the nature of the study and obtained a written informed consent
  7. A legal representative agrees to the trial when a subject is unable to communicate smoothly due to neurologic defect
  8. If a fertile woman who has been confirmed negative to a urine or blood pregnancy test within 28 days prior to the trial

Exclusion Criteria:

  1. Pregnant or breast feeding
  2. Cancer history within 5 years excluding cancer in the skin cells and cervix
  3. Active infections within two weeks
  4. Leptomeningeal metastasis
  5. Patients diagnosed with diabetes
  6. Hypersensitive or intolerance to Metformin
  7. Patients who are currently taking Metformin, sulfonylureas, thiazolidinediones, and insulin, regardless of reason

  8. Other serious diseases or medical conditions that include :

    • Patients who suffer from unstable heart disease despite treatment.
    • Patients having a heart attack within 6 months prior to the start of trial
    • Patients who suffer from severe nerve or psychosis that includes dementia or strokes.
    • Patients with an uncontrolled infection
    • Patient with uncontrolled hypertension, congestive heart failure, unstable angina, or incomplete arrhythmia
  9. Those who have participated in other clinical trials may not recover from the toxicity of the treatment.
Contacts and Locations
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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): NCT03243851


Contacts
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Contact: Yong-Kil Hong, MD., PhD. +82-2-2258-2101 hongyk@catholic.ac.kr
Contact: Seung Ho Yang, MD., PhD. +82-31-249-8304 72ysh@catholic.ac.kr

Locations
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Korea, Republic of
National Cancer Center Korea Recruiting
Ilsan, Gyeonggi-Do, Korea, Republic of, 10408
Contact: Heon Yoo, MD., PhD.    +82-31-920-1249    heonyoo@ncc.re.kr   
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-Do, Korea, Republic of, 13620
Contact: Yu Jung Kim, MD., PhD.    +82-31-787-8210    cong1005@gmail.com   
Ajou University Hospital Recruiting
Suwon-si, Gyeonggi-Do, Korea, Republic of, 16499
Contact: Se Hyuk Kim, MD., PhD.    +82-31-219-3559    nsksh@ajou.ac.kr   
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeollanam-Do, Korea, Republic of, 58128
Contact: Shin Jung, MD., PhD.    +82-2-379-8954    sjung@chonnam.ac.kr   
Incheon St. Mary's Hospital Recruiting
Incheon, Korea, Republic of, 21431
Contact: Dong Sup Chung, MD., PhD.    +82-32-280-5876    dschung@catholic.ac.kr   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Tae Min Kim, MD., PhD.    +82-2-2072-1672    gabriel9@snu.ac.kr   
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jong Hee Chang, MD., PhD.    +82-2-2228-2162    changjh@yuhs.ac   
Konkuk University Hospital Recruiting
Seoul, Korea, Republic of, 05030
Contact: Young Cho Koh, MD., PhD.    +82-2-2030-7622    kohyc@kuh.ac.kr   
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Jeong Hoon Kim, MD., PhD.    +82-2-3010-3559    jhkim1@amc.seoul.kr   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Do Hyun Nam, MD., PhD.    +82-2-3410-3497    nsnam@skku.edu   
Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Yong-Kil Hong, MD., PhD.    +82-2-2258-2101    hongyk@catholic.ac.kr   
Saint Vincent's Hospital, Korea Recruiting
Suwon-si, Korea, Republic of, 16247
Contact: Seung Ho Yang, MD., PhD.    +82-31-249-8304    72ysh@catholic.ac.kr   
Sponsors and Collaborators
Yong-Kil Hong
Saint Vincent's Hospital, Korea
Incheon St.Mary's Hospital
National Cancer Center, Korea
Konkuk University Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Seoul National University Hospital
Asan Medical Center
Ajou University School of Medicine
Severance Hospital
Chonnam National University Hospital
Seoul St. Mary's Hospital
Investigators
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Principal Investigator: Yong-Kil Hong, MD.,PhD. Seoul St. Mary's Hospital
More Information
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Responsible Party: Yong-Kil Hong, MD., PhD., Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03243851     History of Changes
Other Study ID Numbers: KNOG-1501
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yong-Kil Hong, Seoul St. Mary's Hospital:
Glioblastoma
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
Metformin
Temozolomide
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents