Malignant glioma
Conditions
Interventions
Subcutaneous injection of VEGFR1 and VEGFR2 peptides (2mg, respectively) with IFA. Weekly administration, 8 times and then monthly administration, 6 times
total 14 times.
Sponsors
Department of Neurosurgery, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
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 |
|---|---|
| 1) Safety 2) Clinical efficacy Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Immunological responses Induction of in vitro cytotoxic T lymphocytes T lymphocytes analyzed by HLA Tetramer 2) Clinical efficacy Progression-free survival Antitumor effects | — |
Countries
Japan
Contacts
Public ContactMasahiro Toda
Keio University School of Medicine Department of Neurosurgery
Outcome results
None listed