A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with progressive schwannoma from Neurofibromatosis type 2

A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with progressive schwannoma from Neurofibromatosis type 2 - VEGFR 1/2 peptide vaccine for Neurofibromatosis type 2

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023565

Enrollment

Registered

2016-08-09

Start date

2016-08-09

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

Neurofibromatosis type 2 with progressive schwannoma

Interventions

Subcutaneous injection of VEGFR1 and VEGFR2 peptides (2mg, respectively) with IFA. Weekly administration, 4 times and then monthly administration, 4 times

total 8 times.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Progressive schwannoma (Neurofibromatosis 2) without surgical and radiorogical justification 2) announcement of a diagnosis 3) HLA-A*2402,A*0201,A*0206 or A*0207 4) Age between 12 to 79 5) Performance status (ECOG) of 0-2 6) Over 4 weeks after surgery, irradiation, or chemotherapy. 7) Sufficient function of important organs. 8) No uncontrollable pleural, peritoneal or cardiac effusion. 9) Expected survival time: more than 3 months. ] 10) preventing conception 11) 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

Primary

Measure	Time frame
Safety and clinical efficacy of Vaccine therapy using VEGFR1 and VEGFR2 peptide for Neurofibromatosis type 2 with progressive schwannoma.	—

Secondary

Measure	Time frame
1) Progression free survival: PFS 2) Auditory activity: Word recognition scores (WRS), pure tone average (PTA), the American academy of otolaryngology- head and neck surgery (AAO-HNS) classifies hearing loss 3) QoL (Quality of Life): EORTC QLQ-C30, EORTC BN20, MDASI-BT 4) NCF (Neurocognitive Function): MMSE, HVLT-R, TMT, COWA 5) immune reaction (Cytotoxic T lymphocyte (CTL), TCR)	—

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