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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Samsung Medical Center
Seoul, South Korea
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
Time frame: 42 days
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%
Time frame: 4 weeks
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
Time frame: 4 weeks
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 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
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Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Time frame: 4 weeks