Phase I
Study Title: A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy-Refractory Ewing Sarcoma
Study Type: Interventional/nonrandomized/single-group assignment
Study Sponsor and Collaborators: University of Louisville
Purpose: To examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing sarcoma
Primary Outcome Measures: Development of grade 3-4 graft vs host disease [time frame: 12 months]
Principal Investigator: Kenneth Lucas, MD, University of Louisville; 502-852-8450, k0luca01@louisville.edu
ClinicalTrials.gov Identifier: NCT01969942
Study Title: Phase I Study of Olaparib and Temozolomide in Adult Patients With Recurrent/Metastatic Ewing’s Sarcoma Following Failure of Prior Chemotherapy
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Massachusetts General Hospital
Purpose: To find the highest dose of the combination of olaparib and temozolomide that can be given safely to patients with Ewing sarcoma and to collect information about the effects of the combination on Ewing sarcoma
Primary Outcome Measures: Determine maximum tolerated dose of olaparib and temozolomide [time frame: 2 years]
Principal Investigator: Edwin Choy, MD, Massachusetts General Hospital; contact Barbara Anderson, RN, 617-643-2427, banderson15@partners.org
ClinicalTrials.gov Identifier: NCT01858168
Study Title: ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor Niraparib and Temozolomide in Patients With Previously Treated, Incurable Ewing Sarcoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Sarcoma Alliance for Research Through Collaboration
Purpose: To define the dose-limiting toxicities and maximum tolerated dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of temozolomide in patients with pretreated incurable Ewing sarcoma
Primary Outcome Measures: Dose-limiting toxicity and maximum tolerated dose [time frame: approximately 24 months]
Principal Investigator: Multiple locations; contact Sarcoma Alliance Office at 734-930-7600, sarc@sarctrials.org
ClinicalTrials.gov Identifier: NCT02044120
Phase II
Study Title: A Phase II Trial of Irinotecan and Temozolomide in Combination With Existing High-Dose Alkylator-Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center
Purpose: To study what effects adding the combination of irinotecan and temozolomide to the standard EFT chemotherapy regimen has on Ewing sarcoma
Primary Outcome Measures: Event-free survival of patients with localized disease [time frame: 4 years]
Principal Investigator: Heather Magnan, MD, Memorial Sloan Kettering Cancer Center; 212-639-7937
ClinicalTrials.gov Identifier: NCT01864109
Study Title: Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed, metastatic Ewing sarcoma
Primary Outcome Measures: Time to adverse analytic event, defined to be disease-related event, diagnosis of a second malignant neoplasm, or death [time frame: from the time of randomization, assessed up to 5 years]
Principal Investigator: Steven DuBois, MD, Children’s Oncology Group; 255 study locations, see NCI.gov for each institution’s contact
ClinicalTrials.gov Identifier: NCT02306161
Study Title: Phase 2 Solid Tumor Immunotherapy Trial Using HLA-Haploidentical Transplant and Donor Natural Killer Cells: The STIR Trial
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Medical College of Wisconsin
Purpose: To study how well cellular and adoptive immunotherapy using human leukocyte antigen-haploidentical hematopoietic cell transplantation followed by an early, post-transplant infusion of donor natural killer cells on Day +7 is tolerated in this heavily treated population
Primary Outcome Measures: Disease-control rate [time frame: 6 months]
Principal Investigator: Monica Thakar, MD, Medical College of Wisconsin; contact Shelly LeVeque, RN, BSN, 414-266-6471, mleveque@chw.org; or Adam Fiebelkorn, CCRP, MS, 414-266-2137, afiebelk@mcw.edu
ClinicalTrials.gov Identifier: NCT02100891
Study Title: A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing-like Sarcomas
Study Type: Interventional/randomized/crossover assignment
Study Sponsor and Collaborators: Sarcoma Alliance for Research through Collaboration
Purpose: Although regorafenib was approved for use in patients who had progressive gastrointestinal stromal tumor despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. This study looks to examine its effects on multiple sarcomas.
Primary Outcome Measures: Progression-free survival (Ewing/Ewing-like sarcoma) [time frame: up to 16 weeks]
Principal Investigator: Robert Maki, MD, PhD, Tisch Cancer Institute Mount Sinai Medical Center; contact Sarcoma Alliance Office, 734-930-7600, sarc@sarctrials.org
ClinicalTrials.gov Identifier: NCT02048371 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
