Dendritic cell-based vaccine therapy against malignant brain tumor
- Conditions
- Malignant gliomas
- Registration Number
- JPRN-jRCTc040190103
- Lead Sponsor
- Akiyama Yasuto
- Brief Summary
Sixteen newly diagnosed patients with high-grade gliomas were enrolled in a phase II study of the alpha-type-1 DC vaccine. Among 16 patients, 10 showed positive CTL responses to any peptides in an ELISPOT assay. Adverse effects were limited to grade 2 levels. After 6 years of observation, five patients were still alive. Moreover, a significant survival-prolonging effect was verified in DC-treated glioma patients. Peptide-pulsed alpha-type-1 DC vaccines have a potential therapeutic effect on survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 16
1. Histolog ical diagnosis of high-grade glioma (WHO Gr3-4)
2. Standard chemoradiation treatment is supposed to be given after surgery
3. 20< age<80
4. Performance status 0-2
5. Measurable lesions by imaging diagnosis
6. HLA-g enotyping : HLA-A2 or A24
7. No severe organ dysfunction
8. Tolerable and eligible to apheresis performance
9. No severe hemostatic disorders
10. Informed consents obtained
11. Expecting survival with more than 6 months
12. Over 4-week interval after the previous treatment
1. Within 28 days after the last cancer treatment
2. Severe systemic infection, hemostatic dysfunction and organ disorders
3. Steroid treatment except used for cerebral decompression
4. Pregnant women
5. Hypersensitivity to dendritic cell vaccines
6. Severe immunolog ical disorders (autoimmune disease, immunosuppression)
7. Multiple cancers
8. Anaphylaxis to synthetic peptides
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival time
- Secondary Outcome Measures
Name Time Method 1. Relapse-free survival rate at 6 months<br>2. Overall survival time<br>3. Immunolog ical activity after vaccine therapy<br>4. Anti-tumor activity