Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma
NCT ID: NCT03243851
Last Updated: 2021-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2016-11-21
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Temozolomide+Metformin
Low dose temozolomide+metformin for 24 weeks
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
Temozolomide+Placebo
Low dose temozolomide+placebo for 24 weeks
Interventions
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Temozolomide+Metformin
Low dose temozolomide+metformin for 24 weeks
Temozolomide+Placebo
Low dose temozolomide+placebo for 24 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
ALL
No
Sponsors
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Saint Vincent's Hospital, Korea
OTHER
Incheon St.Mary's Hospital
OTHER
National Cancer Center, Korea
OTHER_GOV
Konkuk University Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Asan Medical Center
OTHER
Ajou University School of Medicine
OTHER
Severance Hospital
OTHER
Chonnam National University Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Yong-Kil Hong
OTHER
Responsible Party
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Yong-Kil Hong
MD., PhD.
Principal Investigators
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Yong-Kil Hong, MD.,PhD.
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Locations
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National Cancer Center Korea
Ilsan, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Incheon St. Mary's Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Saint Vincent's Hospital, Korea
Suwon, , South Korea
Countries
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References
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Yoon WS, Chang JH, Kim JH, Kim YJ, Jung TY, Yoo H, Kim SH, Ko YC, Nam DH, Kim TM, Kim SH, Park SH, Lee YS, Yim HW, Hong YK, Yang SH. Efficacy and safety of metformin plus low-dose temozolomide in patients with recurrent or refractory glioblastoma: a randomized, prospective, multicenter, double-blind, controlled, phase 2 trial (KNOG-1501 study). Discov Oncol. 2023 Jun 6;14(1):90. doi: 10.1007/s12672-023-00678-3.
Other Identifiers
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KNOG-1501
Identifier Type: -
Identifier Source: org_study_id
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