Peptides cocktail vaccine for patients with progressive or recurrent malignant glioma.
- Conditions
- malignant gliomaD005909
- Registration Number
- JPRN-jRCTs031180148
- Lead Sponsor
- Toda Masahiro
- Brief Summary
We performed a pilot study for HLA-A2402+ patients with recurrent/progressive high grade gliomas to assess the safety, feasibility, and immunoreactivity of the peptide-based vaccine targeting LY6K, DEPDC1, KIF20A, FOXM1, VEGFR1, VEGFR2. The safety and immunogenicity of this vaccine therapy was verified. The data suggest that this vaccine treatment may show preliminary evidence of clinical responses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 17
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.
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, effectiveness
- Secondary Outcome Measures
Name Time Method tumor volume reduction effect, PFS