Safety and Efficacy of Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Pazopanib
- Conditions
- Relapsed Pediatric Solid Tumor
- Sponsor
- Samsung Medical Center
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
- Status
- Not Yet Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse)
- •Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)"
Exclusion Criteria
- •Patients who had high-dose chemotherapy and autologous stem cell transplantation previously
- •Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction \<40%, significant arrhythmia or conduction disturbance)
- •Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
- •Patients with active bleeding
- •Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents
- •Pregnant or nursing women
- •Patients who can not swallow the pill
Arms & Interventions
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Intervention: Pazopanib
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Intervention: Ifosfamide
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Intervention: Carboplatin
Pazopanib + conventional chemotherapy
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Intervention: Etoposide
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
Time Frame: 42 days
Definition of dose-limiting toxicity (DLT) * Hematologic DLT: delayed recovery of ANC/platelets \> 42 days * Grade 3 creatinine elevation, proteinuria, hyperbilirubinemia, bleeding * Grade 2 arterial thrombosis * Any grade 4 toxicities except hematologic toxicities
Secondary Outcomes
- Rate of tumor response (brain tumor)(4 weeks)
- Rate of tumor response (other solid tumors)(4 weeks)
- Rate of tumor response (neuroblastoma)(4 weeks)