Clinical Trials Logo

Clinical Trial Summary

Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.


Clinical Trial Description

Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03029481
Study type Expanded Access
Source Jonsson Comprehensive Cancer Center
Contact
Status No longer available
Phase

See also
  Status Clinical Trial Phase
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Recruiting NCT06094101 - Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision) Phase 1/Phase 2
Recruiting NCT06029218 - Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy N/A
Completed NCT00743496 - A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma Phase 1
Recruiting NCT04337177 - Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors Phase 1
Active, not recruiting NCT02945800 - Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma Phase 2
Recruiting NCT05968768 - To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly) Phase 2
Recruiting NCT06156410 - Cabozantinib With Ifosfamide in Ewing's Sarcoma and Osteosarcoma Phase 1
Terminated NCT02536183 - A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors Phase 1
Recruiting NCT03715933 - Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas Phase 1
Active, not recruiting NCT03220035 - Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Completed NCT05093322 - A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT02856048 - Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer Phase 2/Phase 3
Withdrawn NCT03880123 - Selinexor in Combination With Ixazomib for the Treatment of Advanced Sarcoma Phase 1
Completed NCT04956198 - Drug Sensitivity and Mutation Profiling
Recruiting NCT04791228 - A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors Phase 2
Recruiting NCT06068075 - Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD N/A
Active, not recruiting NCT03709680 - Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors Phase 1/Phase 2
Recruiting NCT05734066 - Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma Phase 1/Phase 2
Completed NCT02044120 - ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma Phase 1