Phase 1 study of peptide cocktail vaccine for patients with refractory pediatric sarcoma.
- Conditions
- refractory neurobrastoma, Ewing's sarcoma family of tumor, rhabdomyosarcoma and osteosarcoma
- Registration Number
- JPRN-UMIN000010149
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1) Chemotherapy within 3 weeks prior to enrollment. 2) Radiation therapy within 2 weeks prior to enrollment. 3) Major surgery within 1 week prior to enrollment. 4) Allogeneic marrow transplant within 1 year to enrollment, or on-going GVHD. 5) Malignant pleural effusion, ascites or cardiac effusion required invasive treatment. 6) Synchronous or asynchronous (within 5 years) other cancer except carcinoma in situ or intramucosal carcinoma. 7) Active infection requires systemic therapy. 8) Active gastrointestinal bleeding required blood transfusion. 9) Any severe and/or uncontrolled medical conditions. severe interstitial pneumonia history. 10) Severe psychiatric disorder. 11) Known serious drug allergy. 12) Woman during pregnancy, or impossible to discontine breast-feeding for 120 days after the final dose of study treatment. Patient or the partner without intent to use birth control. 13) Inadequate physical condition judged by investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of dose limiting toxicity (DLT)
- Secondary Outcome Measures
Name Time Method Adverse events: AE Disease control rate: DCR Progression free survival: PFS Overall survival: OS