A phase I/II study of maintenance therapy with metformin and temozolomide for newly diagnosed glioblastoma patients

Phase 1

Recruiting

• Conditions: Glioblastoma

• Registration Number: JPRN-jRCTs031200326
• Lead Sponsor: arita Yoshitaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1) Histologically proven Grade IV glioblastoma multiforme (GBM, WHO grade IV glioma)
2) No history of previous therapy for tumor except resection or biopsy.
3) Tumor without cerebellar/stem development confirmed by preoperative MRI.
4) Head MRI before registration revealed no multiple legions or dissemination.
5) Before registration, presence or absence of measurable lesion does not matter.
6) Initial treatment : temozolomide for 30 days or longer with over 50 Gy radiation therapy.
7) Within 49 days from the last irradiation day of the radiotherapy with temozolomide.
8) Aged 20 to 75 years old at registration.
9) KPS (Karnofsky performance status) >= 70
10) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is acceptable.
11) Adequate organ function. Sufficient organ function. The latest test value within 14 days of registration
Neutrophil >= 1,500/mm3
Hb >= 8.0 g /dL
Platelet >= 10X104/mm3
AST <= 150 IU/L
ALT <= 150 IU/L
Estimated g lomerular filtration rate (eGFR) >= 45mL/min/1.73m2(However, eGFR >= 60 mL/min/1.73m2 for patients scheduled to administer metformin 2250 mg /day)
Fasting blood g lucose >= 73mg /dL
HbA1c <= 6.2%
12) Implantation of BCNU wafers during surgery is permitted.TTF tumor treating fields (NovoTTF-100A system) and photodynamic therapy using thalaporphine sodium is not permitted.
13) Written informed consent.

Exclusion Criteria

1) Synchronous(within 2 years) or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy
2) Active infection requiring systemic therapy
3) Active infectious meningitis
4) Body temperature >= 38 degrees Celsius at registration
5) Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding
6) Psychosis or with psychotic symptom
7) Continuous systemic use of steroid or immunosuppressant for disease except for brain tumor
8) History of lactic acidosis
9) History of hypersensitivity to biguanide drugs
10) Diabetes mellitus routine administration of insulin or hypoglycemic agent
11) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 month
12) Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema diagnosed with X-ray test
13) Gadolinium allergy
14) Positive HIV antibody
15) Potitive HBs antigen
16) Any other medical or psychiatric impairments that will prevent administration of protocol therapy in the investigator opinion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I:Dose limiting toxicity (DLT) occurrence rate,Phase II:12-month progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
6-month progression-free survival rate, 12-month progression-free survival rate, 12-month survival rate, overall survival, response rate, adverse event occurrence rate, protocol treatment completion rate