A Phase I study of Glypican-3(GPC3) Peptide Vaccine for Pediatric Patients with Refractory Tumors
Phase 1
- Conditions
- Refractory pediatric tumors
- Registration Number
- JPRN-UMIN000006357
- Lead Sponsor
- Section for Cancer Immunotherapy, Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
1. Pleural effusion or ascites requiring removal by puncture 2. Active concurrent cancer or secondary cancer within 5 disease-free years of primary cancer 3. Active infection requiring systemic medication 4. Active gastrointestinal bleeding 5. Severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled diabetes mellitus 6. Severe psychiatric disorder 7. Past history of severe drug allergy 8. Systemic steroids or immunosuppressant medication 9. Judged inappropriate for the trial by a responsible researcher
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicity
- Secondary Outcome Measures
Name Time Method Progression free survival, overall survival etc. GPC3-specific immune-responses to GPC3 vaccination