Clinical Trials Logo

Clinical Trial Summary

This research study is evaluating the use of specialized testing of solid tumors including sequencing. The process of performing these specialized tests is called tumor profiling. The tumor profiling may result in identifying changes in genes of the tumor that indicate that a particular therapy may have activity. This is called an individualized cancer therapy (iCat) recommendation. The results of the tumor profiling and, if applicable, the iCat recommendation will be returned.


Clinical Trial Description

Patients with extra-cranial (not in the brain) solid tumors that are either difficult to diagnose or more difficult to treat are eligible to participate in this study. All enrolled patients will have targeted sequencing of tumor performed. Sequencing results will be reviewed for clinically significant findings including determination of whether any mutations exist that suggest potential for activity of a targeted therapy (iCat recommendation). Results will be returned to the patient's oncologist and follow-up data will be collected. In this prospective multi-center cohort study, the primary objective is to describe the outcomes of pediatric patients with advanced solid tumors according to whether or not they received of targeted therapy matched to an iCat recommendation. The primary clinical outcome of interest is the endpoint of overall survival (OS), with progression-free survival and response rate (RR) as key secondary clinical outcome measures. To address this hypothesis, 825 patients will enroll from an anticipated 11 participating institutions over 3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02520713
Study type Observational
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase
Start date October 2015
Completion date October 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05151718 - Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents
Recruiting NCT02787876 - Pegteograstim in Children With Solid Tumors Phase 2
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Recruiting NCT05620862 - Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors Phase 1
Recruiting NCT05468359 - Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients Phase 1/Phase 2
Completed NCT04944875 - Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging. N/A
Recruiting NCT03618381 - EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Phase 1
Recruiting NCT04897321 - B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR) Phase 1
Completed NCT05024331 - A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor
Active, not recruiting NCT04483778 - B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Phase 1
Active, not recruiting NCT04239040 - GVAX Plus Checkpoint Blockade in Neuroblastoma Phase 1
Recruiting NCT03739827 - Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Recruiting NCT02339753 - Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT03222258 - Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients
Completed NCT02564198 - A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors Phase 1
Recruiting NCT03273829 - Study of Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children With Relapsed or Refractory Solid Tumors and Leukemias Phase 1
Completed NCT03455140 - A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100) Phase 1/Phase 2
Completed NCT01853345 - iCAT for Recurrent/Refractory/HR Solid Tumors N/A
Active, not recruiting NCT03478462 - Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma Phase 1
Not yet recruiting NCT05322187 - Sequential PD-1/PD-L1 Inhibitor and LENvatinib in TLCT and Refractory Hepatoblastoma After Chemotherapy Phase 2/Phase 3