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 Ectomesenchymoma
- Recurrent Adrenal Gland Pheochromocytoma
- Refractory WHO Grade II Glioma
- Recurrent Ependymoma
- Recurrent Ewing Sarcoma
- Recurrent Hepatoblastoma
- Refractory Ependymoma
- Refractory Medulloblastoma
- Recurrent Rhabdoid Tumor of the Kidney
- Refractory Hepatoblastoma
- Refractory Thyroid Gland Carcinoma
- Refractory Peripheral Primitive Neuroectodermal Tumor
- Recurrent Kidney Wilms Tumor
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Soft Tissue Sarcoma
- Refractory Non Hodgkin Lymphoma
- Refractory Adrenal Gland Pheochromocytoma
- Recurrent Rhabdoid Tumor
- Recurrent Malignant Germ Cell Tumor
- Recurrent WHO Grade II Glioma
- Recurrent Malignant Glioma
- Refractory Rhabdomyosarcoma
- Refractory Malignant Glioma
- Refractory Melanoma
- Refractory Rhabdoid Tumor of the Kidney
- Recurrent Rhabdomyosarcoma
- Refractory Osteosarcoma
- Refractory Soft Tissue Sarcoma
- Refractory Langerhans Cell Histiocytosis
- Recurrent Medulloblastoma
- Recurrent Peripheral Primitive Neuroectodermal Tumor
- Refractory Ewing Sarcoma
- Recurrent Thyroid Gland Carcinoma
- Refractory Malignant Germ Cell Tumor
- Recurrent Melanoma
- Refractory Neuroblastoma
- Refractory Rhabdoid Tumor
- Recurrent Neuroblastoma
- 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 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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