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General Information

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Information About Clinical Trials

 American Cancer Society – Has a “What You Need to Know” and “Clinical Trials Videos” where you can learn more about clinical trials

Cancer Support Community – Provides basic information about clinical trials

Center Watch – Provides information on clinical trials, informed consent, and FDA approved drugs 

MacMillan Cancer Support – Provides information on what clinical trials are, participating in them, giving blood and tissue samples, and how the organization can help

National Cancer Institute (NCI) – Information about clinical trials for patients and caregivers

National Institute of Health (NIH) – Has a “Clinical Trials and You” page that provides answers to common questions regarding clinical trials

Where to Search for Clinical Trials

Acurian – Join Acurian’s patient database for free to receive notifications and information about clinical trials near you. 

Center Watch – Search for clinical trial listings in their database

ClinicalTrials.gov – A database of publicly and privately funded clinical trials worldwide

European Organisation for Research and Treatment of Cancer (EORTC) – A database of clinical trials in Europe and additional countries around the world

Sarcoma Alliance for Research Through Collaboration (SARC) – Lists active sarcoma clinical trials

 

Genetic Testing

Genetic testing has the potential to provide sarcoma patients with increased understanding of their disease and optimal treatment options. Currently there are many for-profit companies that will analyze individual’s DNA and provide information on disease risk and treatment options. These are usually “qualified” findings and recommendations and need to be interpreted and acted on carefully in conjunction with your physician and/or a genetic counselor. There are no agreed on standards for testing or for what biomarkers and genes should be analyzed. The Sarcoma Alliance does not endorse any of these companies or their findings and recommendations. 23andMe is one of these companies and provides DNA analysis for a fee but also has a research study to attempt to better understand genetic biomarkers for sarcoma. There is no charge for participating in their study but any individual findings should be discussed with your health care team.

23andMe Sarcoma Research Initiative – While some researchers strive to understand sarcoma by studying tumor samples, 23andMe wants to work with the patient community to find genetic markers associated with the disease. These markers might help us predict how likely someone is to develop sarcoma or how well a particular treatment will work for a specific patient.

There’s strength in numbers. In order to draw meaningful conclusions, 23andMe hopes to find at least 1,000 qualified individuals who have or have had sarcoma. Using simple online questionnaires they will collect information regarding patients’ experiences, environments and responses to different therapies. They will then combine this information with genetic data to find patterns that will help to better understand the biology of sarcoma. If you are a sarcoma patient or survivor, you can join 23andMe’s research initiative for free by clicking the link above. 

 

 

 

Current Clinical Trials

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CBT-1 in Combination with Doxorubicin in Patients with Metastatic, Unresectable Sarcomas

CBT-1 in Combination with Doxorubicin in Patients with Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin

This study evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6.

More information about this clinical trial is available on ClinicalTrials.gov.

ClinicalTrials.gov Identifier: NCT03002805

Anlotinib in Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, and Synovial Sarcoma (APROMISS)

Phase 3 Trial of Anlotinib in Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma (APROMISS) 

This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.

The Sarcoma Oncology Center in Southern California has created a shareable document with information about this study and contact information for their center for those who are interested or have questions. Anlotinib Clinical Trial PDF

More information on this clinical trial is available on ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT03016819

Dose Escalation and Expansion Trial of NC-6300 (Nanoparticle Epirubicin) in Advanced Soft Tissue Sarcoma

Dose-Escalation and Expansion Trial of NC-6300 in Patients with Advanced Solid Tumors or Soft Tissue Sarcoma

Targeted drug delivery is a method of delivering medication to a patient in a way that will increase the concentration of the drug in certain specific areas of the body more than others. A micelle is a group of molecules naturally produced by our bodies that come together to make an enclosed circle around another molecule in order to safely transport that molecule to somewhere else in the body. In this study, researchers have developed a micelle that will specifically transport the chemotherapy epirubicin into tumors cells only, allowing the chemotherapy to accumulate in tumor cells. This allows the chemotherapy to be delivered to the tumor over a longer period of time in order to increase its effect on the cancer. This therapy is also expected to decrease side effects because the drug is delivered very specifically to the tumor, avoiding toxicity in healthy cells.

The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of the drug will also be studied. The first part of the study will determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended Phase 2 (RPII) dose of NC-6300. The second part of the study will assess the activity and tolerability of NC-6300 in patients with soft tissue sarcoma.

More information on this clinical trial is available on ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT03168061

Dose Escalation Study of reversible LSD1 Inhibitor Seclidemstat (SP-2577) in Patients with Relapsed/Refractory Ewing Sarcoma

Clinical Trial of SP-2577 (Seclidemstat) in Patients with Relapsed/Refractory Ewing Sarcoma

Detailed Description: This phase 1 study is an open-label, non-randomized dose escalation study of SP-2577 administered orally in patients with refractory or recurrent Ewing sarcoma. The study design is based on a Simon’s 4B design.

More information on this clinical trial is available on ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT03600649

 

Efficacy and Safety of tabelecleucel (allogenic EBV-specific T-cell immunotherapy) in patients with EBV+ sarcoma including leiomyosarcoma

An open-label, single-arm, multicohort, Phase 2 study to assess the efficacy and safety of tabelecleucel in subjects with Epstein-Barr virus-associated diseases.

Detailed Description: This is a multi-cohort, Phase 2, single arm, open label study of tabelecleucel (allogenic EBV-specific T-cell immunotherapy) in patients with EBV+ sarcoma, to include leiomyosarcoma (one of six cohorts). Patients can be newly diagnosed or failed a first-line therapy for EBV+ sarcoma. Newly diagnosed patients should be ineligible to receive standard first-line therapy. Primary objective is to evaluate the clinical benefit of tabelecleucel.

More information on this clinical trial is available on ClinicalTrials.gov and Atara Biotherapeutics’ website

ClinicalTrials.gov Identification: NCT04554914

 

 

First Time T-Cell Therapy for Patients with Advanced Tumors (Synovial sarcoma or Myxoid/round cell liposarcoma)

Master Protocol to Assess the Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

This trial will evaluate safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors. They are actively recruiting participants with NY-ESO-1+ advanced (metastatic or unresectable) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS).

Detailed Description: New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1 have shown objective responses. GSK3901961 and GSK3845097 are next generation engineered TCR T-cells, co-expressing the CD8α cell surface receptor, targeting NY-ESO-1, and co-expressing the dnTGF-βRII cell surface receptor, targeting NY-ESO-1, respectively to potentially improve function. This is a master protocol evaluating first time in human T-cell therapies. It will initially consist of two independent substudies, investigating GSK3901961 and GSK3845097 in HLA*A02+ participants with NYESO1+ previously treated advanced (metastatic or unresectable) synovial sarcoma (SS) and/or previously treated metastatic non-small cell lung cancer (NSCLC).

More information about this clinical trial and recruitment is available on ClinicalTrials.gov and GlaxoSmithKline’s website.

ClinicalTrials.gov Identifier: NCT04526509

 

Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue of the Extremity

A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity (SU2C-SARC032)

This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.

Detailed Description: This is a multicenter, randomized phase II trial with an initial safety run-in to test the safety and efficacy of neoadjuvant pembrolizumab with image-guided radiotherapy and adjuvant pembrolizumab compared to radiation therapy alone in patients with clinically localized extremity soft tissue sarcoma at high risk for developing metastatic disease (tumor size > 5 cm, intermediate- to high-grade; approximately 50% risk for distant disease at 2 years). Histologies will be limited to undifferentiated pleomorphic sarcoma and dedifferentiated/pleomorphic liposarcoma based on preliminary data from SARC028. Other terms for undifferentiated pleomorphic sarcoma may include, but are not limited to. pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, pleomorphic fibroblastic sarcoma, undifferentiated high-grade pleomorphic sarcoma, pleomorphicsarcoma with prominent inflammation, pleomorphic sarcoma with giant cells, malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes), fibrosarcoma, and myxofibrosarcoma (located deep to the fascia in muscle). Radiation therapy with three cycles of pembrolizumab will be administered as neoadjuvant therapy for patients randomized to the experimental arm. These patients will also receive up to fourteen cycles of adjuvant pembrolizumab after surgical resection. Patients in the standard of care arm will receive neoadjuvant radiotherapy (50 Gy in 25 fractions) followed by surgical resection as in RTOG 0630.

More information on this clinical trial is available on ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT03092323

 

T-Cell Therapy for Patients with Advanced Tumors (Synovial sarcoma or Myxoid/round cell liposarcoma)

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. They are actively recruiting participants with NY-ESO-1+ advanced (metastatic or unresectable) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS).

Detailed Description: New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene autoleucel (lete-cel, GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor engineered T cells. This is a master protocol investigating T-cell therapies. It will initially consist of a core protocol with two independent substudies investigating Letestresgene autoleucel in previously untreated (1L) Human Leukocyte Antigen (HLA)-A*02+ participants with NY-ESO-1+ advanced (metastatic or unresectable) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS) (Substudy 1) and Letestresgene autoleucel as second line or higher (2L+) treatment in HLA-A*02+ participants with NY-ESO-1+ advanced (metastatic or unresectable) SS or MRCLS who have progressed following treatment with anthracycline based chemotherapy (Substudy 2).

More information about this clinical trial and recruitment is available on ClinicalTrials.gov and GlaxoSmithKline’s website.

ClinicalTrials.gov Identifier: NCT03967223

 

Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma

SAINT: Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma

This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study, previously untreated patients will be enrolled.

This study uses three treatments that have already been FDA approved to treat cancer, although they are not typically all used at the same time. Of the three drugs used in this study, two of them are considered immunotherapy, which means they use different ways to increase the ability of your immune system to fight cancer, and the third is a chemotherapy drug that itself fights and kills cancer cells. Researchers believe that delivering these drugs simultaneously will have a synergistic effect, causing each drug to work better than it normally would on its own. 

For more information about this clinical trial, visit ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT03138161