Tipifarnib for Advanced Solid Tumors, Lymphoma & Histiocytic Disorders with HRAS Gene Alterations in Pediatrics

Active, Not Recruiting Phase 2 NCT04284774

Study Description

This trial studies the effectiveness of Tipifarnib in treating pediatric patients with advanced solid tumors, lymphomas, or histiocytic disorders. Tipifarnib works by blocking cancer cell growth and reducing tumor size in patients with a genetic alteration in HRAS gene. The trial is focused on determining the objective response rate (ORR; complete response + partial response) and the progression-free survival rate in these types of cancers. It also aims to obtain information on the drug's tolerability and evaluate other biomarkers as predictors of response to Tipifarnib. Patients receive Tipifarnib orally or through a nasogastric or gastric tube, with tumor disease evaluation throughout the trial. Blood specimen collections may also be required. After the treatment, patients are followed up.

Study Details

Registry ID:
NCT04284774
Conditions:
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma, Recurrent Ectomesenchymoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Melanoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdoid Tumor of the Kidney, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Thyroid Gland Carcinoma, Recurrent WHO Grade 2 Glioma, Refractory Adrenal Gland Pheochromocytoma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Melanoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdoid Tumor of the Kidney, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory Thyroid Gland Carcinoma, Refractory WHO Grade 2 Glioma
Phase:
Phase 2
Target Enrollment:
5 participants
Start Date:
Age Range:
1–21 years
Healthy Volunteers:
No

Study Locations (199 sites)

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