abdominal/pelvic tumors Desmoplastic round cell tumour
Conditions
Interventions
The following treatments will be administered in this study every 4-week
(28-day) cycle.
Ramucirumab is administered intravenously in a 12mg/kg dose and is a one hour
infusion on day 1 and day 15 o
Sponsors
Eli Lilly
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients with relapsed, recurrent, or refractory DSRCT.- Patients must be 35 months to =16 years of age; Karnofsky et al. 1948) performance score of at least 50.- Patient with adequate hematologic, coagulation, liver, cardiac, renal and bladder function, and adequate blood pressure (BP) control as per protocol.able for thi
Exclusion criteria
Exclusion criteria: - Patients who have had allogeneic bone marrow or solid organ transplant are excluded.- Patients who have active infections requiring therapy.- Patients who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrolment are not eligible.- Patients with a bowel obstruction, extensive intestinal resection or history or presence of inflammatory enteropathy or other GI pathology as per protocol.- Patients with a history of hepatorenal syndrome.- Patients with evidence of active bleeding or a history of significant (>=Grade 3) bleeding event, deep vein thrombosis requiring medical intervention (including pulmonary embolism), hemoptysis or other signs of pulmonary haemorrhage, or esophageal varices within 3 months of enrollment are not eligible.- Patients with a bleeding diathesis or vasculitis are not eligible.- Patients with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months of study enrollment are not eligible.- Patients with myocardial infarction or unstable angina within the prior 6 months.- Patients with significant vascular disease or peripheral vascular disease.- Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible.- Patients who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrolment are not eligible.- Patients previously treated and progressed on combination cyclophosphamide and vinorelbine regimen. (Patients who received combination as maintenance therapy, without progression, would be eligible.)- Patients with known hypersensitivity to cyclophosphamide or vinorelbine.- Patients who have previously received any exposure to ramucirumab are not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of ramucirumab in combination with cyclophosphamide and vinorelbine compared with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT. With it's primary endpoint, Progression Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints for the study are: - To evaluate the safety and tolerability of ramucirumab in combination with cyclophosphamide and vinorelbine compared with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT. - To evaluate the efficacy of ramucirumab in combinationwith cyclophosphamide and vinorelbine compared with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT. With endpoints Overall Response Rate (ORR), Duration of Response (DoR) & Complete Response (CR) - To characterize the PK of ramucirumab when co-administered with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT. - To assess the immunogenicity of ramucirumab when co-administered with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT | — |
Countries
Netherlands
Outcome results
None listed