VEGFR1/2 peptide vaccine for patients with primary malignant glioma

Phase 1

Recruiting

• Conditions: malignant glioma; Malignant glioma; D005910

• Registration Number: JPRN-jRCTs031180170
• Lead Sponsor: Toda Masahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1)malignant glioma
2) HLA-A*2402, A*0201, A*0206, A*0207
3) Age between 16 to 79
4) Performance status (ECOG) of 0-2
5) After the postoperative treatment of irradiation with concurrent temozolomide.
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) 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
1) Safety <br>2) Clinical efficacy <br>Overall survival

Secondary Outcome Measures

Name	Time	Method
1) Immunological responses <br>Induction of in vitro cytotoxic T <br>lymphocytes <br>T lymphocytes analyzed by HLA Tetramer <br>2) Clinical efficacy <br>Progression-free survival <br>Antitumor effects