Phase II single-arm studies of gemcitabine in combination with oxaliplatin in refractory and relapsed pediatric solid tumors
Phase 2
Completed
- Conditions
- solid tumors in children10027655
- Registration Number
- NL-OMON29764
- Lead Sponsor
- Institue Goustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
- relapsed or refractory pediatric solid tumors
- age 6 months up to 21 years
- measurable primary and/or metastatic disease
- no more than 1 salvage therapy for relapse
- Lansky play score over 60 or ECOG 1
- adequate organ function
- life expectancy > 3 months
- wash out or prior therapy of 3 weeks
- written informed consent
Exclusion Criteria
- Other antitumor therapy
- pre-existing sensory or motor neuropathy >grade 2 (except when caused by tumor)
- allergic reaction to platinum compounds
- symptomatic brain metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess teh objectiev response rate in children with relapsed/refractory<br /><br>solid tumors in whom standard treatment has failed.<br /><br>The response rate will be assessed per startum, and the study includes 5<br /><br>different strata:<br /><br>- medulloblastoma<br /><br>- neuroblasoma<br /><br>- osteosarcoma<br /><br>- miscelleneous slid tmors (non-brain)<br /><br>- miscelleneous brain tumors.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives are the safety, the duration of response, the time to<br /><br>progression and survival, and the value of PET-scans in the response evaluation<br /><br>of osteosarcoma.</p><br>