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

Refractory Pediatric Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03628131
• Other study ID #: 2017-11-147
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2018
• Est. completion date: July 2025

Study information

• Verified date: September 2018
• Source: Samsung Medical Center
• Contact: Ki Woong Sung, MD, PhD
• Phone: 82-2-3410-3529
• Email: kiwoong.sung[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: July 2025
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Refractory Pediatric Solid Tumor
• Relapsed Pediatric Solid Tumor

Intervention

Drug:
• Pazopanib
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
• Ifosfamide
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
• Carboplatin
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
• Etoposide
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy	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	42 days
Secondary	Rate of tumor response (neuroblastoma)	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%	4 weeks
Secondary	Rate of tumor response (brain tumor)	- 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	4 weeks
Secondary	Rate of tumor response (other solid tumors)	- 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 suf?cient shrinkage to qualify for PR nor suf?cient increase to qualify for PD; PD: At least a 20% increase in the sum of diameters of target lesions	4 weeks