Conditions: Neoplasms Solid Tumors Bone Cancer Kidney Tumor Neuroblastoma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

Brief summary:
This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH 717454, MK-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in conformance with Good Clinical Practices. This study will evaluate the safety, tolerability and dose-finding of robatumumab when administered in combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and vincristine (Arm B), or ifosfamide and etoposide (Arm C).

The primary study hypothesis is that robatumumab can be safely administered in combination with chemotherapy regimens in pediatric participants with solid tumors.

Detailed description:

Arms:
arm 1: Participants receive temozolomide 100 mg/m\^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle. arm 2: Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle. arm 3: Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.

Interventions: intervention 1: Temozolomide intervention 2: Vincristine intervention 3: Ifosfamide intervention 4: Irinotecan intervention 5: Robatumumab intervention 6: Doxorubicin intervention 7: Cyclophosphamide intervention 8: Etoposide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol document: