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Table 3 Principal vaccines trials in sarcoma treatment

From: Is immunotherapy in the future of therapeutic management of sarcomas?

NCI trial number

Drug

Type of sarcoma

Study design

Phase

Status

NCT01803152

Dendritic Cells Vaccine

Metastatic sarcomas

The patient's dendritic cells used for the vaccine are loaded with tumor lysate. There are three intended dose levels of DC cells per treatment. The vaccine is somministred with topical imiquimod (an immune response modifier), with or without the inhibition of MDSC by gemcitabine pre-treatment

I

Active, not recruiting

NCT01241162

Dendritic cell vaccine with adjuvant

Ewings sarcoma, Osteogenic sarcoma, Rhabdomyo sarcoma, Synovial Sarcoma, Neuroblastoma

The dendritic cells used for the vaccine production, was pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3. The administration of DC vaccine is preceded by decitabine as a demethylating chemotherapy

I

Completed

NCT00027911

NY-ESO-1 peptide vaccine + Sargramostim

Soft tissue sarcoma

Patients receive NY-ESO-1 peptide vaccine and receive sargramostim (GM-CS), recombinant granulocyte macrophage colony-stimulating factor, before every vaccination

I

Terminated

NCT04433221

Multiple CAR-T cells and sarcoma vaccines

Stage III, IV sarcoma patients or recurrent sarcoma patients;

This trial combines CAR T cells with low dose chemotherapy and followed by maintenance sarcoma vaccines. Chemotherapy, as doxorubicin, is used for the purpose of modulating surface PD-L1 level and enhance immunotherapy effects

I/II

Recruiting

NCT01258868

Tumor cell vaccine + ISCOMATRIX Adjuvant

Thoracic sarcomas,mesolthelioma,

Esophageal cancer, lung cancer

Patients are vaccinated with autologous tumor cells exposed ex vivo to decitabine,a hypomethylating agent and radiation. Vaccine is administered in conjunction with ISCOMATRIX adjuvant, that induces both humoral and cellular immune responses and with oral celecoxib, an anti-inflammatory

I

Terminated

NCT00020267

MAGE-12 peptide vaccine

Soft tissue sarcoma, ovarian sarcoma, melanoma,

Colon, lung, breast cancer

Patients received MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant subcutaneously (SC) weekly for 4 doses (arm A) or once every 3 weeks for 4 doses (arm B). Patients with PD could receive IL-2, with the purpose of increasing the immune response

I

Completed

NCT04166006

Dendritic cell vaccine + Interleukin-2

Soft tissue sarcoma, Neuroendocrine tumors, rare cancer

Patients inject with autologous DC vaccine, that it is followed by subcutaneous injection daily of IL-2, as adjuvant to increase the efficacy of vaccine

II

Recruiting

NCT01141491

Trivalent ganglioside vaccine + OPT-821

Sarcoma

Patients received the vaccine combined with OPT-821, an immune system stimulant (arm A) or the immune system stimulant alone (arm B). The trivalent vaccine should stimulate the immune system to recognize GM2, GD2 and GD3 that are present primarily on sarcoma cells

II

Completed

NCT00001566

Dendritic cells + indinavir sulfate

Pediatric ES Rhabdomyosarcoma

Peptide-pulsed antigen presenting cell (APC) vaccine is injected into patients. Following chemotherapy, infusion of harvested T cells followed by infusion of peptide-pulsed APC vaccinations. IL-2 is administered on the same day as T cell /peptide-pulsed infusions

II

Completed

NCT01341496

Tumor cell vaccines + ISCOMATRIX

Sarcoma, melanoma, epithelial Malignancies

The autologous tumor cell vaccine is administered with ISCOMATRIX adjuvant in combination with metronomic oral cyclophosphamide and celecoxib in patients undergoing thoracic metastasectomy

I

Terminated

NCT03357315

Mix vaccine

Metastatic sarcomas

Patients received mix vaccine (experimental group) or not received treatments (control group). The aim of the study is to evaluate safety and efficacy of mix vaccine on small metastases of sarcoma

I/II

Completed