Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Recurrent Rhabdomyosarcoma
  • Recurrent Adrenal Gland Pheochromocytoma
  • Recurrent Ectomesenchymoma
  • Recurrent WHO Grade II Glioma
  • Recurrent Rhabdoid Tumor of the Kidney
  • Refractory Adrenal Gland Pheochromocytoma
  • Recurrent Ependymoma
  • Refractory Langerhans Cell Histiocytosis
  • Refractory Ewing Sarcoma
  • Recurrent Non-Hodgkin Lymphoma
  • Refractory Malignant Germ Cell Tumor
  • Refractory Medulloblastoma
  • Refractory Peripheral Primitive Neuroectodermal Tumor
  • Refractory WHO Grade II Glioma
  • Recurrent Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Ewing Sarcoma
  • Refractory Osteosarcoma
  • Refractory Neuroblastoma
  • Refractory Rhabdomyosarcoma
  • Recurrent Hepatoblastoma
  • Refractory Soft Tissue Sarcoma
  • Refractory Ependymoma
  • Refractory Malignant Glioma
  • Recurrent Osteosarcoma
  • Recurrent Soft Tissue Sarcoma
  • Refractory Hepatoblastoma
  • Recurrent Kidney Wilms Tumor
  • Recurrent Langerhans Cell Histiocytosis
  • Recurrent Malignant Germ Cell Tumor
  • Recurrent Malignant Glioma
  • Refractory Melanoma
  • Recurrent Medulloblastoma
  • Recurrent Neuroblastoma
  • Refractory Non Hodgkin Lymphoma
  • Refractory Thyroid Gland Carcinoma
  • Recurrent Melanoma
  • Refractory Rhabdoid Tumor
  • Refractory Rhabdoid Tumor of the Kidney
  • Recurrent Rhabdoid Tumor
  • Recurrent Thyroid Gland Carcinoma
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 tipifarnib with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alter...

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with tipifarnib with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in HRAS. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with tipifarnib with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in HRAS. II. To obtain information about the tolerability of tipifarnib in children and adolescents with relapsed or refractory cancer. EXPLORATORY OBJECTIVES: I. To evaluate other biomarkers as predictors of response to tipifarnib and specifically, whether tumors that harbor different missense mutations or variant allele frequency will demonstrate differential response to tipifarnib treatment. II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive tipifarnib orally (PO) or via nasogastric or gastric tube twice daily (BID) on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then periodically thereafter.

Tracking Information

NCT #
NCT04284774
Collaborators
Not Provided
Investigators
Principal Investigator: Christine A Pratilas Children's Oncology Group