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Clinical trial of Novo-TTF-100A for recurrent glioblastoma

Clinical trial of Novo-TTF-100A for recurrent glioblastoma - Novo-TTF for recurrent GBM

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015769
Enrollment
20
Registered
2014-11-28
Start date
2014-11-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent glioblastoma

Interventions

NovoTTF-100A is composed with transducer array sheets, leads and a connection box.Transducer array sheets should be attached on frontal, occipital and bilateral temporal regions of the patients.The ma
s consent.

Sponsors

Osaka Medical College, Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who agreed to participate in this clinincal study in writing after receiving sufficient explanation. 2) Patients with definitive progression of GB on MR, CT or PET scans. 3)The patient should be diagnosed as GB by histology. 4) The patient should be treated by stndard of care such as radiation, chemotherapy with TMZ and/or bevacizumab. 4) KPS is 30% or more. 5) Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration. a) neutrophil count more than 1,500 /mm3 b) Hemoglobin level more than 10.0 g/dL c) Platelet count more than 10.0 x 104 /micro L d) Serum creatine level less than 1.4 mg/dL e) ALT levels less than 100 IU/L f) AST levels less than 100 IU/L g) Total birirubin less than1.5 mg/dL

Exclusion criteria

Exclusion criteria: 1) Patients with the infra-tentorial lesions. 2) Patients received with pacemakers or shuntting devices with magnet actions. 3) Pateients with sever systemic complications, necessary for hospitalization. 4) Patients with unhealed scalp wound. 5) Patients with infectious diseses,necessary for antibiotics, so on. 6) Female patients in definitive or possible pregnancy or in breast-feeding. 7) Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator.

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
Tumor response Adverse effects

Countries

Japan

Contacts

Public ContactShin-Ichi Miyatake

Osaka Medical College Cancer Center

neu070@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026