Refractory pediatric tumors
Conditions
Interventions
Intradermal injection of HLA-A24 or A2 restricted GPC3 peptide emulsified with Montanide ISA51 adjuvant, 1.5 mg/dose, repeating every 2 weeks, until disease progression/recurrence.
Sponsors
Section for Cancer Immunotherapy, Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Refractory pediatric tumors 1) Patients in refractory, recurrent, or progressive status (progressive group) 2) Patients in remission without chance of cure (remission group) 3) Patients in partial remission or stable disease (partial remission group) 2. Patients with histological confirmation of GPC3 expression in tumor cells 3. 1-19 year-old of age 4. ECOG performance status of 0-2 5. Confirming the following laboratory results within 14 days 1) Absolute neutrophil count >=1,000/mm3 2) Platelet count >= 75,000/mm3 3) Creatinine adjusted according to age as follows: <= 0.8 mg/dl (<5 years) <= 1.2 mg/dl (5 years-9 years) <= 1.5 mg/dl (10 years-19 years) 4) Serum total Bilirubin <= 1.5mg/dl and ALT <= 165 IU/l 6. More than 28 days since prior antitumor cytotoxic treatment 7. Sixteen to 19 year-old of age: written informed consent from both patient and legal guardian Fifteen years and under: written informed consent from legal guardian 8. HLA-A24 or -A2 positive
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survival etc. GPC3-specific immune-responses to GPC3 vaccination | — |
Countries
Japan
Contacts
Public ContactAko Hosono
National Cancer Center Hospital East Department of Pediatric Oncology
Outcome results
None listed