Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase II Trial of ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer
The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG20), an extracellular arginine depleting enzyme, the investigators demonstrated ADI-PEG20 induces a prosurvival metabolic reprogramming in ASS1-deficient sarcomas that redirects glucose into the serine/folate pathway directing the carbons from glucose into pyrimidine biosynthesis, thus sensitizing cells to death by the pyrimidine antimetabolite gemcitabine by using metabolomics. The synthetic lethality was increased by the addition of docetaxel. Therefore a phase II clinical trial of ADI with gemcitabine and docetaxel, a standard second line therapy for soft tissue sarcoma will be conducted to determine if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by ADI-PEG20. Recently published data shows that priming ASS1-deficient tumors with ADI-PEG 20 and docetaxel improves the effect of gemcitabine. Therefore, a cohort of patients consisting of ten patients diagnosed with either osteosarcoma or Ewing's sarcoma (ideally five of each), and five patients diagnosed with small cell lung cancer will be included as an exploratory cohort. Enrollment to Cohort 2 will occur concurrently with Cohort 1.
n/a
| 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 | |
| Active, not 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 |
NCT00611078 -
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
|
N/A | |
| Completed |
NCT00580320 -
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
|
Phase 1 | |
| 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 |