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)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Hepatoblastoma
- Recurrent Childhood Ependymoma
- Advanced Malignant Solid Neoplasm
- Refractory Hepatoblastoma
- Recurrent Ewing Sarcoma
- Refractory Neuroblastoma
- Recurrent Glioma
- Recurrent Kidney Wilms Tumor
- Refractory Ependymoma
- Refractory Glioma
- Refractory Non Hodgkin Lymphoma
- Recurrent Rhabdomyosarcoma
- Refractory Medulloblastoma
- Recurrent Osteosarcoma
- Refractory Malignant Germ Cell Tumor
- Refractory Osteosarcoma
- Refractory Soft Tissue Sarcoma
- Refractory Rhabdoid Tumor
- Recurrent Rhabdoid Tumor
- Recurrent Langerhans Cell Histiocytosis
- Refractory Malignant Glioma
- Refractory Peripheral Primitive Neuroectodermal Tumor
- Refractory Rhabdomyosarcoma
- Recurrent Malignant Germ Cell Tumor
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Malignant Glioma
- Recurrent Medulloblastoma
- Recurrent Neuroblastoma
- Refractory Ewing Sarcoma
- Refractory Langerhans Cell Histiocytosis
- Recurrent Peripheral Primitive Neuroectodermal Tumor
- Recurrent Soft Tissue Sarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 1221 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: 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 ...
PRIMARY OBJECTIVE: 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 OBJECTIVE: 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. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT03526250
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rajen Mody Children's Oncology Group
Get Well Soon