Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Malignant Germ Cell Tumor
- Recurrent Ependymoma
- Recurrent Ewing Sarcoma
- Refractory Malignant Glioma
- Refractory Non Hodgkin Lymphoma
- Refractory Osteosarcoma
- Refractory Hepatoblastoma
- Refractory Malignant Solid Neoplasm
- Refractory Soft Tissue Sarcoma
- Recurrent Hepatoblastoma
- Recurrent Langerhans Cell Histiocytosis
- Refractory Malignant Germ Cell Tumor
- Refractory Medulloblastoma
- Refractory Neuroblastoma
- Refractory Langerhans Cell Histiocytosis
- Recurrent Rhabdoid Tumor
- Recurrent Soft Tissue Sarcoma
- Refractory Ewing Sarcoma
- Recurrent WHO Grade II Glioma
- Refractory Rhabdoid Tumor
- Recurrent Malignant Glioma
- Refractory Ependymoma
- Refractory Peripheral Primitive Neuroectodermal Tumor
- Recurrent Malignant Solid Neoplasm
- Wilm's Tumor
- Recurrent Medulloblastoma
- Refractory Rhabdomyosarcoma
- Recurrent Neuroblastoma
- Refractory WHO Grade II Glioma
- Recurrent Peripheral Primitive Neuroectodermal Tumor
- Recurrent Rhabdomyosarcoma
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Osteosarcoma
- 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
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