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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Brain Cancer
Ewing Sarcoma
Germ Cell Tumor
Liver/ Hepatoblastoma
Lymphoma
Neuroblastoma
Unknown Primary
Trial Phase
Phase II
Eligibility
12 Months - 21 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03526250
Protocol IDs
APEC1621I (primary)
APEC1621I
NCI-2018-00863
Study Sponsor
Childrens Oncology Group

Summary

This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVES:
I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with palbociclib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in cell cycle genes.

SECONDARY OBJECTIVES:
I. To estimate the progression free survival in pediatric patients treated with palbociclib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in alterations in cell cycle genes.
II. To obtain information about the tolerability of palbociclib in children and adolescents with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:
I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
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