VEGFR 1/2 peptide vaccine for Neurofibromatosis type 2

Phase 1

• Conditions: eurofibromatosis type 2 with progressive schwannoma; Neurofibromatosis type 2; D016518

• Registration Number: JPRN-jRCTs031180184
• Lead Sponsor: Toda Masahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1) Progression free survival: PFS <br>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 <br>3) QoL (Quality of Life): EORTC QLQ-C30, EORTC BN20, MDASI-BT <br>4) NCF (Neurocognitive Function): MMSE, HVLT-R, TMT, COWA <br>5) immune reaction (Cytotoxic T lymphocyte (CTL), TCR)