Refractory Pediatric Solid Tumor, Relapsed Pediatric Solid Tumor
Conditions
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
Interventions
DRUGPazopanib
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
DRUGIfosfamide
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
DRUGCarboplatin
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
DRUGEtoposide
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Sponsors
Ministry of Health, Republic of Korea
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 22 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| 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 |
Countries
South Korea
Contacts
Primary ContactKi Woong Sung, MD, PhD
Outcome results
None listed