Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
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|ClinicalTrials.gov Identifier: NCT03526250|
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : January 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm RB1 Positive Recurrent Childhood Ependymoma Recurrent Ewing Sarcoma Recurrent Glioma Recurrent Hepatoblastoma Recurrent Kidney Wilms Tumor Recurrent Langerhans Cell Histiocytosis Recurrent Malignant Germ Cell Tumor Recurrent Malignant Glioma Recurrent Medulloblastoma Recurrent Neuroblastoma Recurrent Non-Hodgkin Lymphoma Recurrent Osteosarcoma Recurrent Peripheral Primitive Neuroectodermal Tumor Recurrent Rhabdoid Tumor Recurrent Rhabdomyosarcoma Recurrent Soft Tissue Sarcoma Refractory Ependymoma Refractory Ewing Sarcoma Refractory Glioma Refractory Hepatoblastoma Refractory Langerhans Cell Histiocytosis Refractory Malignant Germ Cell Tumor Refractory Malignant Glioma Refractory Medulloblastoma Refractory Neuroblastoma Refractory Non-Hodgkin Lymphoma Refractory Osteosarcoma Refractory Peripheral Primitive Neuroectodermal Tumor Refractory Rhabdoid Tumor Refractory Rhabdomyosarcoma Refractory Soft Tissue Sarcoma||Other: Laboratory Biomarker Analysis Drug: Palbociclib Other: Pharmacological Study||Phase 2|
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.
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.
I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 22, 2018|
|Estimated Primary Completion Date :||March 30, 2023|
|Estimated Study Completion Date :||March 30, 2023|
Experimental: Treatment (palbociclib)
Patients receive palbociclib PO QD on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Objective response rate defined as a patient who achieves a best response of partial response or complete response on the study [ Time Frame: Up to 5 years ]Confidence intervals will be constructed using the Wilson score interval method.
- Progression free survival (PFS) [ Time Frame: From the initiation of protocol treatment to disease progression or disease recurrence or death from any cause, assessed up to 5 years ]PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
- Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 5 years ]
- Pharmacokinetic (PK) parameters [ Time Frame: Up to 5 years ]PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid [ Time Frame: Baseline up to 5 years ]A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526250
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|Principal Investigator:||Rajen Mody||Children's Oncology Group|