Name | Type | Description | Interventions |
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Experimental phase I dose escalating | Experimental | Prospective open-labeled phase I trial.
Combination of cyclophosphamide and JX-594 dose escalation. Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as designated by assigned dose-level, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.
Number of subjects : 14 | - Cyclophosphamide and JX-594 dose escalation
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Experimental group soft-tissue sarcoma, treatment by JX-594 + Metronomic cyclophosphamide | Experimental | Randomized non comparative phase II clinical trial : Arm 1.
Experimental phase II soft-tissue sarcoma :
Combination of cyclophosphamide and JX-594. Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as the dose recommended in the experimental phase I dose escalating study, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.
Number of subjects : 48 | - Cyclophosphamide and JX-594
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Control group soft-tissue sarcoma, treatment by JX-594 + Metronomic cyclophosphamide | Experimental | Randomized non comparative phase II clinical trial : Arm 2.
Control-arm phase II soft-tissue sarcoma :
Patients will be treated by metronomic cyclophosphamide. Cyclophosphamide will be administered 50 mg twice daily orally, one week on/one week off. One cycle consits of 28 days.
Number of subjects : 24 | |
Experimental group breast cancer, treatment by JX-594 + Metronomic cyclophosphamide | Experimental | Single-arm phase II clinical trial.
Experimental phase II Group breast cancer :
Combination of cyclophosphamide and JX-594. Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as the dose recommended in the experimental phase I dose escalating study, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.
Number of subjects : 32 | - Cyclophosphamide and JX-594
|
Experimental group soft-tissue sarcoma, treatment by Avelumab + ITJX-594 + Metronomic CP | Experimental | Experimental phase II soft-tissue sarcoma :
Combination of avelumab in combination with intratumoral JX-594 and metronomic cyclophosphamide.
Avelumab will be administered by intravenous infusion every 2 weeks, starting at Day 15 of cycle 1.
Cyclophosphamide wil be administered orally, 50 mg twice daily, one Week on/one Week off, starting 7 days prior to cycle 1 day 1 ("impregnation phase").
JX-594 will be administered by intratumoral injection on day 1 of cycle 1, every 2 weeks, for a maximum of 4 injections.
Number of subjects : 47 | - Avelumab and JX-594 and Cyclophosphamide
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Experimental group breast cancer, treatment by Avelumab + IT JX-594 + Metronomic CP | Experimental | Experimental phase II breast cancer :
Combination of avelumab in combination with intratumoral JX-594 and metronomic cyclophosphamide.
Avelumab will be administered by intravenous infusion every 2 weeks, starting at Day 15 of cycle 1.
Cyclophosphamide wil be administered orally, 50 mg twice daily, one Week on/one Week off, starting 7 days prior to cycle 1 day 1 ("impregnation phase").
JX-594 will be administered by intratumoral injection on day 1 of cycle 1, every 2 weeks, for a maximum of 4 injections.
Number of subjects : 32 | - Avelumab and JX-594 and Cyclophosphamide
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