Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Recurrent Hepatoblastoma
  • Recurrent Ependymoma
  • Wilm's Tumor
  • Refractory Ependymoma
  • Refractory Rhabdoid Tumor
  • Refractory Malignant Solid Neoplasm
  • Recurrent Ewing Sarcoma
  • Recurrent WHO Grade II Glioma
  • Refractory Ewing Sarcoma
  • Refractory Rhabdomyosarcoma
  • Refractory Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Peripheral Primitive Neuroectodermal Tumor
  • Refractory Hepatoblastoma
  • Refractory Malignant Glioma
  • Recurrent Langerhans Cell Histiocytosis
  • Recurrent Malignant Germ Cell Tumor
  • Recurrent Malignant Glioma
  • Refractory Langerhans Cell Histiocytosis
  • Recurrent Malignant Solid Neoplasm
  • Refractory Medulloblastoma
  • Refractory Non Hodgkin Lymphoma
  • Recurrent Medulloblastoma
  • Refractory WHO Grade II Glioma
  • Refractory Malignant Germ Cell Tumor
  • Refractory Soft Tissue Sarcoma
  • Recurrent Neuroblastoma
  • Recurrent Non-Hodgkin Lymphoma
  • Refractory Osteosarcoma
  • Recurrent Rhabdomyosarcoma
  • Refractory Neuroblastoma
  • Recurrent Rhabdoid Tumor
  • Recurrent Osteosarcoma
  • 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 AG-120 (ivosidenib) with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating gene...

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with AG-120 (ivosidenib) with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the IDH1 pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with AG-120 (ivosidenib) with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the IDH1 pathway. II. To obtain information about the tolerability of AG-120 (ivosidenib) in children and adolescents with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics and pharmacodynamics of AG-120 (ivosidenib) in children and adolescents with relapsed or refractory cancer. EXPLORATORY OBJECTIVES: I. To evaluate other biomarkers as predictors of response to AG-120 (ivosidenib) and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to AG-120 (ivosidenib) treatment. II. To explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive ivosidenib orally (PO) once daily (QD). 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 #
NCT04195555
Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Elizabeth D Alva Children's Oncology Group