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Leiomyosarcoma Clinical Trial Listings

New Clinical Trial Updates- 

  • Dr. Breelyn Wilky in Miami said they recently started enrolling people with LMS (and other soft-tissue sarcoma) in a phase III clinical trial of anlotinib, an immunotherapy drug. This is a randomized, controlled trial. LMS patients will be selected at random to receive either anlotinib or dacarbazine. https://clinicaltrials.gov/show/NCT03016819
Anti-Osteoclast Therapy as Neoadjuvant in Treatment of Chondrosarcoma – Phase 1b Trial
Phase:phase 1
Start Date:July 2017
Conditions:chondrosarcoma, sarcoma
Biology of Osteosarcoma (BOOST) Registry and Biobank
Start Date:January 2017
Conditions:sarcoma, bone sarcoma, osteosarcoma
Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma
Phase:phase 2
Start Date:October 2015
Conditions:bone sarcoma, osteosarcoma, sarcoma
Treatments:denosumab, biomarker
A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity
Phase:phase 2
Start Date:July 2017
Conditions:sarcoma, soft tissue sarcoma

NCI – MATCH CLINICAL TRIAL-Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma

From the National Cancer Institute (NCI)  –  an NCI MATCH Clinical Trial to link targeted cancer drugs to gene abnormalities.  This is a molecular analysis for therapy choice.  The trial will seek to determine whether targeted therapies for patients whose tumors have specific gene mutations will be effective regardless of their cancer type.

NCI-Match will incorporate more than 20 different study drugs or drug combinations, each targeting specific gene mutations in order to match each patient in the trial with a therapy that targets a molecular abnormality in their tumor.

Enrollment in the NCI-MATCH will be available across the country through NCTN sites and will also be available through sites nationwide that participate in the NCI Community Oncology Research Program – 2,400 sites can participate in the Trial.

The trial is currently recruiting participants:


Dr. Robert Maki outlines solid tumor trials and their importance in sarcoma treatment in the link below:

Click here to view a list of LMS related clinical trials and the status of these trials –  to know about and discuss with your oncologist – to follow the results or be a possible candidate for an active recruitment opportunity.

Thank you

Annie Achee
National Leiomyosarcoma Foundation

1. Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery

Detailed Description: This randomized phase II/III trial studies how effective pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in combination with pazopanib hydrochloride or combination chemotherapy in treating patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by surgery. Click here for more information.

2. Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

Detailed Description: This randomized phase III trial examines how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma that was previously removed by surgery. Click here for more information.

3.Identification of microRNA biomarkers for response of advanced soft tissue sarcomas to eribulin: Translational results of the EORTC 62052 trial

Detailed Description: The expression level of specific microRNAs in soft tissue sarcoma tissue samples might predict response to eribulin.

Click here for the full study

4.  A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas

Detailed Description: The purpose of this study is to determine the effectiveness of pembrolizumab in patients with advanced sarcomas.

Click here for the full study

5. Short, full-dose adjuvant chemotherapy (CT) in high-risk adult soft tissue sarcomas (STS): long-term follow-up of a randomized clinical trial from the Italian Sarcoma Group and the Spanish Sarcoma Group.

Detailed Description: This trial compares the effectiveness of a standard neoadjuvant chemotherapy with epirubicin plus ifosfamide versus a histology-driven chemotherapy, (i.e. a chemotherapy tailored to the specific histology within the family of adult STS) for the treatment of localized high-risk soft tissue sarcomas (STS).

Click here for the full study

6. A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma

Detailed Description: The purpose of this trial is to assess possible biomarkers and method of action, effictiveness and safety of olaratumab in individuals with soft tissue sarcoma (STS).

Click here for the full study

7. A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma

 Detailed Description: The purpose of this trial  is to assess the safety and effectiveness of two anti-cancer drugs (gemcitabine and docetaxel) with and without olaratumab in partients with advanced soft tissue sarcoma (STS) or metastatic STS (STS that has spread to another part(s) of the body).
Click here for the full study

8. A Phase II Study of Tivozanib in Patients with Metastatic and Nonresectable Soft-Tissue Sarcomas

Detailed Description: Tivozanib is well tolerated and showed antitumor activity against metastatic STSs. Researchers conducted further studies to determine the clinical efficacy of tivozanib in soft tissue sarcoma (STS).

Click here for the full study


9. Observational – Potentially Actionable Mutations in Archived Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

Detailed Description: This trial studies genes in tumor tissue samples of soft tissue sarcomas from young and adolescent patients to analyze DNA  and determine which specific mutations are linked to disease characteristics such as tumor stage, histological grade, or outcome.

Click here for the full study

10. A Phase I/ Randomized Phase II Study of MLN0128 vs. Pazopanib in Patients With Locally Advanced/Unresectable and/or Metastatic Sarcoma

Detailed Description: This partially randomized phase I/II trial studies the side effects and optimal dosing of sapanisertib (an oral raptor-mTOR and rictor- mTOR inhibitor) and observes its efficacy in comparision to pazopanib hydrochloride in treating sarcomas that are too large to be removed or that have spread to other areas of the body.  Sapanisertib and pazopanib hydrochloride both inhibit the growth of tumor cells by blocking enzymes that are needed for cell growth.

Click here for the full study

11. Administration Of LMP-Specific Cytotoxic T-Lymphocytes To Patients With Relapsed EBV-Positive Lymphoma

Detailed Description: In this study, researchers are determining whether LMP specific cytotoxic T lymphocytes (CTLs) (special immune system cells) can prevent or treat Epstein-Barr Virus (EBV) Disorder. Some patients with Leiomyosarcoma exhibit signs  of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or during their diagnosis.

Click here for the full study

12.  Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

Detailed Description: The purpose of this research study is to determine if administering dexrazoxane in combination with doxorubicin affects the progression of advanced soft tissue sarcoma.

Click here for the full study

13. A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

Detailed Description: The main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab in combination with radiation for sarcomas is still under investigation.

Click here for the full study

14. A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma

Detailed Description: The purpose of this phase II trial is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in patient with soft tissue sarcoma.

Click here for the full study

15. Ignyta Announces Interim Data from RXDX-101 Phase I Clinical Trial at 2014 ESMO Congress

Detailed Description- Ignyta, Inc. , a biotechnology company that develops precision medicine for cancer patients, presented interim data results from the ALKA-372-001 Phase I clinical trial of RXDX-101, an oral tyrosine inhibitor that targets solid tumors,  at the 2014 Congress of the European Society for Medical Oncology (ESMO) in Madrid, Spain.

 Click here for the full study

16.  STARTRK-2 Clinical Trial-Currently Recruiting