Soft Tissue Sarcoma Clinical Trial
Official title:
Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)
This will be a prospective pilot study that will evaluate 20 patients who were diagnosed with FNCLCC Grade 2 or 3 soft tissue sarcomas and will undergo surgical resection. Based upon the FDA label, successful protocols used for intraoperative fluorescence-guided visualization for glioma resections, and on drug company current dosing recommendation for this study, patients will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to surgery. The use of 5-ALA fluorescence will be relevant for evaluating the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.
PRIMARY OBJECTIVE: I. Demonstrate the feasibility of 5-ALA-aided fluorescent visualization of STS versus surrounding tissues. SECONDARY OBJECTIVE: I. Demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. II. Assess the safety profile of fluorescence-guided surgery (FGS) for STS utilizing 5-ALA. OUTLINE: Patients will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to surgical resection. Intraoperative fluorescence-guided visualization will be used for evaluating the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02910895 -
A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)
|
N/A | |
| Recruiting |
NCT05621668 -
A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma
|
Phase 1 | |
| Active, not recruiting |
NCT04032964 -
Dose Finding Study of L19TNF and Doxorubicin in Patients With STS
|
Phase 1 | |
| Recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01650077 -
Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
|
||
| Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 | |
| Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
| Completed |
NCT02204111 -
Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
|
||
| Withdrawn |
NCT01663090 -
Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas
|
N/A | |
| Completed |
NCT01259375 -
Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma
|
Phase 2 | |
| Completed |
NCT01440088 -
A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
|
Phase 3 | |
| Completed |
NCT01106872 -
Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas
|
Phase 1 | |
| Recruiting |
NCT00753727 -
Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT00755261 -
Phase II Study of Doxorubicin and Avastin® in Sarcoma.
|
Phase 2 | |
| Completed |
NCT00580320 -
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
|
Phase 1 | |
| Completed |
NCT00611078 -
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
|
N/A | |
| Completed |
NCT03452644 -
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
|
||
| Recruiting |
NCT05539677 -
Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
|
||
| Terminated |
NCT03520959 -
A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
|
Phase 3 |