Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue Sarcoma
This phase II trial studies the side effects of talimogene laherparepvec and radiation therapy and to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery (resectable). Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.
PRIMARY OBJECTIVE: I. To estimate the pathologic complete necrosis rate (the number of patients with >= 95% necrosis divided by the number of evaluable patients) following preoperative treatment with talimogene laherparepvec (T-VEC) in combination with radiation in patients with localized soft tissue sarcoma including a pre-planned interim safety analysis to assess post-surgical wound complications. SECONDARY OBJECTIVES: I. To estimate the toxicity of talimogene laherparepvec (T-VEC) in combination with radiation in localized soft tissue sarcomas, during neo-adjuvant treatment and post-surgical resection wound complications. II. To estimate the rate of radiologic response, prior to surgery, and extent of surgical resection. III. To estimate time to surgery, time to progression, time to recurrence, and death. CORRELATIVE OBJECTIVES: I. To characterize the clinical outcomes within three distinct histologic subtypes: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and undifferentiated pleomorphic sarcoma. II. To characterize the percentage of tumor necrosis in treated tumors. III. To assess if the combination of preoperative talimogene laherparepvec (T-VEC) with radiation will increase the expression of PD-L1 in soft tissue sarcomas. IV. To assess the impact of preoperative talimogene laherparepvec (T-VEC) with radiation on the tumor infiltrating and circulating immune cells in patients with soft tissue sarcomas. OUTLINE: Patients receive talimogene laherparepvec intratumorally (IT) or via intralesional injection at weeks 1, 4, 6 and 8. Beginning 1 week after the start of talimogene laherparepvec, patients undergo radiation therapy on Monday-Friday of weeks 2-6. Patients undergo collection of blood and a tumor biopsy on study and undergo magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every year for up to 5 years. ;
| 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 |
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 |
NCT01259375 -
Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma
|
Phase 2 | |
| 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 |