Clinical Trials Actively Recruiting Patients With Soft-Tissue Sarcomas

The information contained in this Clinical Trials Resource Guide includes details of actively recruiting clinical studies of children and adults with various types of soft-tissue sarcoma, including non-rhabdomyosarcoma, Ewing sarcoma, gastrointestinal stromal tumor, and Kaposi sarcoma. The studies presented here are interventional, nonrandomized, and randomized and include pilot, phase I, phase I/II, phase II, and phase II/III studies investigating gene therapy; toll-like receptor 4 (TLR4) agonist GLA-SE and radiation therapy; diagnostic imaging; single-agent and combination chemotherapies; and vaccine therapy. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

Study Type: Interventional/single-group assignment

Study Title: A Pilot Study to Determine the Safety of the Combination of Stable-Emulsion Formulation of Glucopyranosyl Lipid A (GLA-SE) With Radiation in Patients With Metastatic Sarcoma

Study Sponsor and Collaborators: Fred Hutchinson Cancer Research Center; National Cancer Institute

Purpose: To study the side effects of toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable-emulsion when given together with radiation therapy in the treatment of patients with sarcoma that has metastasized

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Incidence of severe adverse events, defined as any grade 3 or higher adverse advent according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (time frame: up to week 9)

Principal Investigator: Seth Pollack, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-667-6629

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02180698

Study Title: Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma

Study Sponsor and Collaborators: Vanderbilt-Ingram Cancer Center; National Cancer Institute

Purpose: To use changes in 3 Tesla MRI measurements of tumor protein content, cell density, and microvessel perfusion obtained before and after a single cycle of neoadjuvant chemotherapy (NAC) to predict eventual tumor response observed at the conclusion of NAC in patients with osteosarcoma or Ewing sarcoma

Ages Eligible for Study: 13 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Percent change in MRI metrics (time frame: pretreatment and end of neoadjuvant cycle 1)

Principal Investigator: Vicky Keedy, MD, Vanderbilt-Ingram Cancer Study. Contact: VICC Clinical Trials Information Program at 800-811-8480.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01882231

Study Title: Pilot Study: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) for Assessing Tumor Vascularity and Permeability in Soft-Tissue Sarcoma Treated With Preoperative Radiotherapy Followed by Surgical Resection

Study Sponsor and Collaborators: University of Utah

Purpose: To determine the diagnostic value of dynamic contrast enhancing MRI (DCE-MRI) in soft-tissue sarcoma for assessment of tumor radiographic changes in vascular permeability and microvessel density before and after preoperative radiotherapy

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility (time frame: 36 months)

Principal Investigator: Ying Hitchcock, MD, Huntsman Cancer Institute. Contact: Crelley Mackey; 801-581-3916, crelley.mackey@hci.utah.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01575951

Study Title: A Pilot Study to Test Whether Systemic Interferon Gamma Increases Tumor Class I MHC Expression in Patients With Synovial Sarcoma and Myxoid/ Round Cell Liposarcoma

Study Sponsor and Collaborators: Fred Hutchinson Cancer Research Center; National Cancer Institute

Purpose: To study the effect of recombinant interferon gamma on tissue in treating patients with soft-tissue sarcoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Change in class 1 MHC expression after treatment with IFN gamma as determined by immunohistochemistry (time frame: baseline up to 2 weeks postsurgery)

Principal Investigator: Seth Pollack, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-667-6629

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01957709

Study Title: The Effect of Antiangiogenic Therapy With Pazopanib Prior to Preoperative Chemotherapy for Subjects With Extremity Soft-Tissue Sarcomas: A Randomized Study to Evaluate Response by Imaging

Study Sponsor and Collaborators: University of Washington; National Cancer Institute

Purpose: To assess pazopanib hydrochloride followed by chemotherapy and surgery in treating patients with soft-tissue sarcoma. Giving pazopanib hydrochloride and chemotherapy before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Absolute values and changes in maximum standardized uptake value of tumors measured by FDG-PET pre- and post-receipt of pazobanib vs placebo, and post-receipt of two courses of preoperative chemotherapy (time frame: at baseline and 14 days)

Principal Investigator: Robin L. Jones, MD, MRCP, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-288-7439

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01446809

Study Type: Phase I/interventional/single-group assignment

Study Title: A Study To Determine the Feasibility of Treating Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Using Autologous NY-ESO-1 Specific CD8+ T Cells With Cyclophosphamide Pre-Conditioning but Without the Use of IL-2

Study Sponsor and Collaborators: Fred Hutchinson Cancer Research Center; National Cancer Institute

Purpose: To study the side effects and best way to give genetically engineered NY-ESO-1-specific T lymphocytes after cyclophosphamide in the treatment of patients with advanced synovial sarcoma or myxoid/round cell liposarcoma

Ages Eligible for Study: 18 to 85 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Incidence of grade 3 or greater toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: up to 10 weeks)

Principal Investigator: Seth Pollack, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-667-6629

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02059850

Study Title: Phase I Study of Dasatinib in Combination With Ipilimumab for Patients With Advanced Gastrointestinal Stromal Tumor and Other Sarcomas

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To investigate the side effects and best dose of dasatinib when given in combination with ipilimumab in the treatment of patients with gastrointestinal stromal tumors or other sarcomas that cannot be removed by surgery or have metastasized

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose defined as the highest dose studied for which the observed incidence of dose-limiting toxicity is less than 33% according to the National Cancer Institute Common Toxicity Criteria (time frame: up to week 12)

Principal Investigator: Richard D. Carvajal, MD, Memorial Sloan Kettering Cancer Center; 646-888-4161, carvajar@mskcc.org.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01643278

Study Title: A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma

Study Sponsor and Collaborators: University of Louisville; Solving Kids’ Cancer

Purpose: To test the effectiveness of an autologous cancer testis (CT) antigen specific dendritic cell vaccine preceded by decitabine as a demethylating chemotherapy in patients with relapsed high-risk neuroblastoma, Ewing sarcoma, osteogenic sarcoma, rhabdomyosarcoma, or synovial ­sarcoma

Ages Eligible for Study: 1 to 17 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Tolerance of study treatment (time frame: 2 years)

Principal Investigator: Kenneth G. Lucas, MD, University of Louisville, Kosairs Children Charities Pediatric Clinical Research Unit; 502-582-0043, k0luca01@louisville.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01241162

Study Title: A Phase I Trial of Dendritic Cell Vaccination With and Without Inhibition of Myeloid Derived Suppressor Cells by Gemcitabine Pre-Treatment For Children And Adults With Sarcoma

Study Sponsor and Collaborators: University of Miami

Purpose: To test whether the use of adjuvant vaccination with autologous dendritic cells matured in situ after being loaded with tumor lysates derived from autologous refractory sarcoma tissue will be safe, feasible, and potentially beneficial for patients with sarcoma

Ages Eligible for Study: 1 year and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Number of participants with adverse events as a measure of safety and tolerability (time frame: 3 years)

Principal Investigator: John Goldberg, MD, University of Miami; jgoldberg2@med.miami.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01803152

Study Type: Phase I/II/interventional/nonrandomized/parallel assignment

Study Title: Phase I/II Trial of Mithramycin in Children and Adults With Refractory Extracranial Solid Tumors (Phase I) or Ewing Sarcoma and EWSFLI1 Fusion Transcript (Phase II)

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study whether mithramycin is safe and effective against solid tumors and Ewing sarcoma in children and adults

Ages Eligible for Study: 1 year and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Determine the tolerability, toxicity, and recommended dose of mithramycin in pediatric patients with extracranial tumors (time frame: 2 years)

Principal Investigator: Brigitte C. Widemann, MD, National Cancer Institute; 301-496-7387, widemanb@pbmac.nci.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01610570

Study Title: A Phase I/II Study of the Safety, Pharmacokinetics and Efficacy of Pomalidomide (CC-4047) in the Treatment of Kaposi Sarcoma in Individuals With or Without HIV

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To test whether pomaldomide is a safe and effective treatment for Kaposi sarcoma in people with or without HIV

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Assess the safety, tolerability, and pharmacokinetics of pomalidomide in people with Kaposi sarcoma, whether HIV associated or not, at a dose derived from solid tumor studies (time frame: 6-12 months)

Principal Investigator: Robert Yarchoan, MD, National Cancer Institute; 301-496-0328, robert.yarchoan@nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01495598

Study Type: Phase II/interventional/nonrandomized/single-group assignment

Study Title: Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To determine whether AZD2171 is effective in young patients with alveolar soft part sarcoma, a type of cancer that develops in tissues that connect, support, or surround other organs in the body

Ages Eligible for Study: Up to 16 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To determine if pediatric patients with alveolar soft part sarcoma will experience at least a minimal response rate when treated with AZD2171 (time frame: 2 cycles)

Principal Investigator: Shivaani Kummar, MD, National Cancer Institute; 301-435-0517, kummars@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00942877

Study Title: Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft-Tissue Sarcomas

Study Sponsor and Collaborators: Massachusetts General Hospital; Brigham and Women’s Hospital, Children’s Hospital Boston, Dana-Farber Cancer Institute, National Institutes of Health

Purpose: To assess the short- and long-term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft-tissue sarcomas

Ages Eligible for Study: Up to 30 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Acute and late toxicities (time frame: 3 years)

Principal Investigator: Torunn Yock, MD, Massachusetts General Hospital; 617-724-1836

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00592293

Study Type: Phase II/III/interventional/randomized/parallel assignment

Study Title: Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft-Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus ­Pazopanib

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To test how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares to radiation alone or in combination with pazopanib hydrochloride or combination chemotherapy in the treatment of newly diagnosed non-rhabdomyosarcoma soft-tissue sarcomas that can be removed by surgery

Ages Eligible for Study: 2 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Potential benefit for chemoradiotherapy plus pazopanib hydrochloride defined as protocol week 13 pathologic response (phase II) (time frame: week 13)

Principal Investigator: Aaron R. Weiss, DO, Children’s Oncology Group; 207-396-8090, wrighd@mmc.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02180867 ■