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Phase I/IIa trial of autologous tumor vaccine and temozolomide administration in patients with primary glioblastoma

Phase I/IIa trial of autologous tumor vaccine and temozolomide administration in patients with primary glioblastoma - Autologous tumor vaccine and temozolomide for glioblastoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001426
Enrollment
25
Registered
2008-11-01
Start date
2008-10-01
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

Glioblastoma

Interventions

Sponsors

University of Tsukuba
Lead Sponsor
Tokyo Womens Medical University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) WHO histological grade IV glioblastoma in(GBM) supratentrial brain without dissemination. 2) Maximum surgical resection was performed. 3) 1.5 g of tumor was reserved in fixed specimen. 4) Karnofsky performance scale is equal to or more than 60 %. 5) 60 Gy of radiation will be performed. 6) Informed consent is obtained from each patient 7) Vaccination and follow-up of each patient is possible to perform within the institutions of this study. 8) Lymphocyte count in peripheral blood is 1000/mm3 or more.

Exclusion criteria

Exclusion criteria: 1) Patients who have been administered or are taking corticosteroid or anticancer drugs. 2) Patients with high intracranical pressure. 3) Patients with severe myelosupression. 4) Patients with severe complication including hematopathy 5) Patients with malignant tumor or cancer. 6) Pregnant or nursing woman, or woman willing to be pregnant. 7) Patients participate in other study during or within 6 months before temozolomide administration in this study. 8) Other reasons for exclusion

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
Cause-specific survival Progression-free survival Tumor-regression rate, disease-control rate QOL Neurological improvement

Countries

Japan

Contacts

Public ContactEiichi Ishikawa

University of Tsukuba Department of Neurosurgery, Doctoral Program in Functional and Regulatory Medical Science, Graduate

e-ishikawa@md.tsukuba.ac.jp029-853-3220

Outcome results

None listed

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