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Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03243851
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yong-Kil Hong
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yong-Kil Hong, MD.,PhD.
Principal Investigator Affiliation	Seoul St. Mary's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

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 : 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 2nd to 6th cycle (20 weeks) = 2,000mg/day

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: 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 2nd to 6th cycle (20 weeks) = 2,000mg/day

Interventions

Drug: - Temozolomide+Metformin

Low dose temozolomide+metformin for 24 weeks

Drug: - Temozolomide+Placebo

Low dose temozolomide+placebo for 24 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.