A Phase 2 Single-Arm study of gemcitabine in combination with Oxaliplatin in Pediatric patients with relapsed or refractory neuroblastoma or miscellaneous solid non-CNS tumors - ND

• Conditions: Patients with neuroblastoma and Miscellaneous Solid NOn-CNS tumor; MedDRA version: 6.1Level: HLGTClassification code 10027655

• Registration Number: EUCTR2005-005219-36-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1 Histologically proven malignancy at diagnosis either neuroblastoma or other non-CNS solid tumors excluding osteosarcoma . 2 Measurable primary and/or metastatic disease 3 Relapsed or refractory tumors in which standard approaches to treatment have failed. 4 No more than one salvage therapy for relapsed or refractory disease. 5 6 months to 18 years of age. 6 Lansky play score 70 , or Eastern Cooperative Oncology Group ECOG performance status 1 where more appropriate . 7 Life expectancy 3 months. 8 Adequate organ function
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 2 Concurrent administration of any other antitumor therapy. 3 Have a serious concomitant systemic disorder for example, active infection including HIV, or cardiac disease that, in the opinion of the investigator, would compromise the patient s ability to complete the study. 4 Have symptomatic brain metastases. 5 Pre-existing sensory or motor neuropathy Grade 2 excluding neuropathy due to disease .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified