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Soft Tissue Sarcoma clinical trials

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NCT ID: NCT03618381 Recruiting - Neuroblastoma Clinical Trials

EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults

Start date: June 18, 2019
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a EGFR-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express EGFR and the selection-suicide marker EGFRt. EGFRt is a protein incorporated into the cell with our EGFR receptor which is used to identify the modified T cells and can be used as a tag that allows for elimination of the modified T cells if needed. On Arm A of the study, research participants will receive EGFR-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at EGFR and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. The CD19 receptor harbors a different selection-suicide marker, HERtG. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the subject's body on each arm. Subjects will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each arm. Subjects who experience significant and potentially life-threatening toxicities (other than clinically manageable toxicities related to T cells working, called cytokine release syndrome) will receive infusions of cetuximab (an antibody commercially available that targets EGFRt) or trastuzumab (an antibody commercially available that targets HER2tG) to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products.

NCT ID: NCT03602833 Active, not recruiting - Soft-tissue Sarcoma Clinical Trials

Phase I Study Compound 451238 and Radiotherapy in Soft-tissue Sarcoma

Start date: November 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this trial is to assess the safety and tolerability of combining compound 451238 and radiotherapy, treating advanced STS.

NCT ID: NCT03546127 Completed - Soft Tissue Sarcoma Clinical Trials

Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study

MULTIPLI-0
Start date: May 23, 2017
Phase:
Study type: Observational

Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.

NCT ID: NCT03524898 Terminated - Soft Tissue Sarcoma Clinical Trials

NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma

Start date: October 2, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

A clinical trial with biweekly regimen of gemcitabine and nab-paclitaxel for Soft tissue sarcomas (STSs). A Promising antitumor activity in patients with metastatic STS has been reported with gemcitabine alone or in combination with taxanes including docetaxel and paclitaxel in pre-treated patients. Nab-paclitaxel is a 130-nm albumin-bound formulation of paclitaxel particles (Celgene, Summit, NJ) which was designed to eliminate the toxicities associated with Cremophor®-EL. Nab-paclitaxel at equal dose of paclitaxel showed increased antitumor activity, enhanced endothelial cell transport and 33% higher intra-tumor paclitaxel concentration in preclinical models of solid tumor xenografts promising an advantageous pharmacokinetic profile In sarcoma, nab-paclitaxel demonstrated preclinical anti-tumor activity in rhabdomyosarcoma xenograft model. Local relapsed tumors following paclitaxel treatment proved to be paclitaxel-resistant but remained responsive to nab-paclitaxel. These findings provide the rationale for further evaluation of nab-paclitaxel in combination with gemcitabine for soft tissue sarcoma treatment.

NCT ID: NCT03520959 Terminated - Cancer Clinical Trials

A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

NCT ID: NCT03514381 Completed - Soft Tissue Sarcoma Clinical Trials

Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

IPIAP-STM
Start date: May 18, 2018
Phase: Phase 4
Study type: Interventional

This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant. The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre. Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.

NCT ID: NCT03508726 Active, not recruiting - Soft Tissue Sarcoma Clinical Trials

High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas

Start date: June 27, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-arm open-label phase Ib/II clinical study assessing the efficacy of concurrent high dose ascorbate in combination with radiotherapy in patients with locally advanced, resectable, high grade sarcomas.

NCT ID: NCT03475953 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

REGOMUNE
Start date: May 4, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial). Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.

NCT ID: NCT03468075 Terminated - Sarcoma Clinical Trials

Gemcitabine Plus Ascorbate for Sarcoma in Adults

Start date: July 11, 2018
Phase: Phase 2
Study type: Interventional

This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.

NCT ID: NCT03462316 Active, not recruiting - Soft Tissue Sarcoma Clinical Trials

NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma

Start date: May 21, 2018
Phase: Phase 1
Study type: Interventional

The main purpose of this trial is to investigate the safety and tolerability of NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)in the first-line treatment failed advanced bone and soft tissue sarcoma. The secondary purpose of this trial is to investigate the efficacy of NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)in the first-line treatment failed advanced bone and soft tissue sarcoma.