Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors

Samsung Medical Center

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Refractory Pediatric Solid Tumor; Relapsed Pediatric Solid Tumor

Treatments: Drug: Carboplatin; Drug: Pazopanib; Drug: Etoposide; Drug: Ifosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03628131

2017-11-147

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 2 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Pazopanib + conventional chemotherapy

Experimental group

Description:

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Treatment:

Drug: Ifosfamide

Drug: Etoposide

Drug: Carboplatin

Drug: Pazopanib