VEGFR 1/2 peptide vaccine for Neurofibromatosis type 2

JRCT ID: jRCTs031180184

Registered date:05/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neurofibromatosis type 2 with progressive schwannoma
• Date of first enrollment: 28/09/2016
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Subcutaneous injection of VEGFR1 and VEGFR2 peptides (2mg, respectively) with IFA. Weekly administration, 4 times and then monthly administration, 4 times; total 8 times. Peptides are injected 8 times every week (plus or minus 2 days), then 6 times monthly thereafter (plus or minus 7 days).

Outcome(s)

• Primary Outcome: Safety and clinical efficacy of Vaccine therapy using VEGFR1 and VEGFR2 peptide for Neurofibromatosis type 2 with progressive schwannoma.

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 79age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Toda Masahiro
• Secondary ID(s): UMIN000023565