Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Hepatoblastoma
- Recurrent Adrenal Gland Pheochromocytoma
- Refractory WHO Grade II Glioma
- Refractory Osteosarcoma
- Refractory Thyroid Gland Carcinoma
- Refractory Ewing Sarcoma
- Refractory Langerhans Cell Histiocytosis
- Refractory Rhabdomyosarcoma
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Osteosarcoma
- Refractory Malignant Glioma
- Recurrent Ectomesenchymoma
- Recurrent Ependymoma
- Recurrent Ewing Sarcoma
- Refractory Non Hodgkin Lymphoma
- Refractory Rhabdoid Tumor of the Kidney
- Recurrent Rhabdoid Tumor
- Refractory Neuroblastoma
- Recurrent Kidney Wilms Tumor
- Recurrent Neuroblastoma
- Refractory Adrenal Gland Pheochromocytoma
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Peripheral Primitive Neuroectodermal Tumor
- Recurrent Rhabdoid Tumor of the Kidney
- Refractory Medulloblastoma
- Recurrent Malignant Germ Cell Tumor
- Recurrent Malignant Glioma
- Recurrent Soft Tissue Sarcoma
- Refractory Soft Tissue Sarcoma
- Recurrent Rhabdomyosarcoma
- Refractory Peripheral Primitive Neuroectodermal Tumor
- Refractory Ependymoma
- Refractory Rhabdoid Tumor
- Refractory Malignant Germ Cell Tumor
- Recurrent Thyroid Gland Carcinoma
- Recurrent WHO Grade II Glioma
- Refractory Hepatoblastoma
- Recurrent Medulloblastoma
- Recurrent Melanoma
- Refractory Melanoma
- 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
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