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A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma.

A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma. - Peptides cocktail vaccine for patients with progressive or recurrent malignant glioma.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012774
Enrollment
20
Registered
2014-01-08
Start date
2013-12-01
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

Malignant glioma

Interventions

Subcutaneous injections of URLC10, DEPDC1, FOXM1, KIF20A, VEGFR1 and VEGFR2 peptides (1mg, respectively) with IFA. Weekly administration, total 8 times.

Sponsors

Department of Neurosurgery, Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) malignant glioma. 2) HLA-A*2402. 3) Age between 16 to 79. 4) Performance status (ECOG) of 0-2. 5) After the postoperative treatment with temozolomide and irradiation. 6) Over 4 weeks after chemotherapy and/or irradiation 7) Sufficient function of important organs. 8) No uncontrollable pleural, peritoneal or cardiac effusion. 9) Expected survival time: more than 3 months. 10) Written informed consents are obtained.

Exclusion criteria

Exclusion criteria: 1) Uncontrollable severe infectious diseases. 2) Serious concomitant diseases 3) Adverse event of NCI-CTC grade 3 or 4. 4) Unable to take anything orally over 24 hours. 5) Active multiple cancers. 6) Myeloproliferative diseases such as MDS and CML. 7) After allogeneic hematopoietic stem cell transplantation. 8) Active autoimmune diseases. 9) Severe drug allergy 10) Necessity for administration of steroid or immunosuppressive drugs. 11) Pregnancy or lactation. Patients hope pregnancy 12) Psychiatric disorders. 13) Unhealed injury. 14) Judged as inappropriate for this study by doctors.

Design outcomes

Secondary

MeasureTime frame
1) Immunological responses Induction of in vitro cytotoxic T lymphocytes T lymphocytes analyzed by HLA Tetramer 2) Clinical efficacy Progression-free survival Antitumor effects

Primary

MeasureTime frame
1) Safety 2) Clinical efficacy Overall survival

Countries

Japan

Contacts

Public ContactMasahiro Toda

Keio University School of Medicine Department of Neurosurgery

todam@keio.jp03-5363-3808

Outcome results

None listed

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