Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
  • Advanced Malignant Solid Neoplasm
  • Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
  • Low Grade Glioma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Malignant Glioma
  • Refractory Langerhans Cell Histiocytosis
  • Refractory Primary Central Nervous System Neoplasm
  • Recurrent Childhood Ependymoma
  • Rhabdoid Tumor
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Refractory Non Hodgkin Lymphoma
  • Recurrent Langerhans Cell Histiocytosis
  • Wilm's Tumor
  • Recurrent Primary Central Nervous System Neoplasm
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Medulloblastoma
  • Recurrent Osteosarcoma
  • Recurrent Childhood Non-Hodgkin Lymphoma
  • Recurrent Neuroblastoma
  • Refractory Malignant Solid Neoplasm
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Recurrent Hepatoblastoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Malignant Solid Neoplasm
  • Refractory Neuroblastoma
  • Recurrent Childhood 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 OBJECTIVES: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with JNJ-42756493 (erdafitinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that ha...

PRIMARY OBJECTIVES: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with JNJ-42756493 (erdafitinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor genetic alterations in the FGFR1/2/3/4 pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with JNJ-42756493 (erdafitinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor genetic alterations in the FGFR1/2/3/4. II. To obtain information about the tolerability of JNJ-42756493 (erdafitinib) in children with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics of JNJ-42756493 (erdafitinib) in children 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 erdafitinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Tracking Information

NCT #
NCT03210714
Collaborators
Not Provided
Investigators
Principal Investigator: Alice Lee Children's Oncology Group