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

Phase 1

Not yet recruiting

• Conditions: Refractory Pediatric Solid Tumor; Relapsed Pediatric Solid Tumor
• Interventions: Drug: Pazopanib; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide

• Registration Number: NCT03628131
• Lead Sponsor: Samsung Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-14
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19
• Study Start: 2018-10
• Primary Completion: 2023-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pazopanib + conventional chemotherapy	Pazopanib	Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Pazopanib + conventional chemotherapy	Ifosfamide	Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Pazopanib + conventional chemotherapy	Carboplatin	Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Pazopanib + conventional chemotherapy	Etoposide	Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy	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 Outcome Measures

Name	Time	Method
Rate of tumor response (brain tumor)	4 weeks	- as assessed by 2-dimensional measurement (the product of the tumor's longest diameter and its longest perpendicular diameter); * CR: complete disappearance of all previously measurable tumors.; * PR: greater than 50% decrease in tumor size; * SD: less than 50% reduction in tumor size or less than 25% increase in tumor size; * PD: greater than 25% increase in tumor size or the appearance of a new tumor
Rate of tumor response (other solid tumors)	4 weeks	- as assessed by The Response Evaluation Criteria in Solid Tumors (RECIST version 1.1); * CR: Disappearance of all target lesions.; * PR: At least a 30% decrease in the sum of diameters of target lesions; * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; * PD: At least a 20% increase in the sum of diameters of target lesions
Rate of tumor response (neuroblastoma)	4 weeks	* as assessed by International Neuroblastoma Response; * Primary tumor: CT and/or MRI; MIBG scan if available; * Metastatic sites: bone marrow biopsies, CT/MRI, MIBG scan; * CR (Complete response): No tumor (primary \& metastatic); * VGPR (Very good PR): Decreased by 90-99% (primary) \& no tumor (metastatic); * PR (Partial response): Decreased by \> 50% (primary \& metastatic); * MR (Mixed response): \> 50% reduction of any measurable lesion (primary or metastases) with \< 50% reduction in any other; \< 25% increase in any existing lesion; * SD (Stable disease): No new lesions; \< 50% reduction but \< 25% increase in any existing lesion.; * PD (Progressive disease): Any new lesion; increase of any measurable lesion by \> 25%

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of