Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03226236
Status:
WITHDRAWN
Last Update Posted:
2018-11-13
First Post:
2016-09-28
Brief Title:
Vaccination With Dendritic Cells Pulsed With Autologous Tumor Homogenate in Combination With HD-IL2 and Immunomodulating Radiotherapy in Metastatic RCC
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
Vaccination With Dendritic Cells Pulsed With Autologous Tumor Homogenate in Combination With HD-IL2 and Immunomodulating Radiotherapy in Metastatic RCC a Phase II Trial RENALVax-2
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients enrolled due to change in standard practice
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RENALVax-2
Brief Summary:
Single center open-label Proof of Principle phase II trial to assess objective response ORR
Three daily doses boost radiotherapy XRT at 6-12 Gy to at least 1 and up to a maximum of 5 metastatic fields will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccineIL-2 The first day of administration of vaccine is day 1 and of IL-2 is day 2
Treatment vaccine plus IL-2 dose 18 MIUm2day in 500cc by continuous IV infusion for 72 hours will be administered every 3 weeks up to 6 cycles
Total duration of the trial 36 months
Enrolment period 24 months
Treatment maximum of 6 cycles 5 months per patient
Follow-up every three months until patient died follow-up until PD and only survival contacts and subsequent therapy for metastatic disease after PD
Three daily doses boost radiotherapy XRT at 6-12 Gy to at least 1 and up to a maximum of 5 metastatic fields will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccineIL-2 The first day of administration of vaccine is day 1 and of IL-2 is day 2
Treatment vaccine plus IL-2 dose 18 MIUm2day in 500cc by continuous IV infusion for 72 hours will be administered every 3 weeks up to 6 cycles
Total duration of the trial 36 months
Enrolment period 24 months
Treatment maximum of 6 cycles 5 months per patient
Follow-up every three months until patient died follow-up until PD and only survival contacts and subsequent therapy for metastatic disease after PD
Detailed Description:
Vaccination with dendritic cells pulsed with autologous tumor homogenate in combination with HD-IL2 and immunomodulating radiotherapy in metastatic RCC a phase II trial Proof of Principle phase II study Study Design Single center open-label trial to assess response rate Study Duration Total duration 36 months Enrollment 24 months Treatment 5 months per patient Follow-up every three months Primary objectives Overall Response Rate ORR by irRC
Secondary end points
1 Toxicity
2 Overall Survival
3 Duration of response
4 PFS
5 ORR by RECIST 11
6 Prognostic and predictive marker response
7 Immunological response Study Product Dose Route Regimen and duration of administration Three daily doses boost radiotherapy XRT at 6-12 Gy to at least 1 and up to a maximum of 5 metastatic fields will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccineIL-2 The first day of administration of vaccine is day 1 and of IL-2 is day 2
The intradermal autologous dendritic cell vaccine loaded with autologous tumor homogenate plus IL-2 dose 18 MIUm2day in 500cc by continuous IV infusion for 72 hours will be administered every 3 weeks up to 6 cycles
Statistical Methodology
This is a Proof of Principle trial with a minimax two stage design
Step 1 12 patients enrolled A 5 response rate will preclude further study whereas a 20 response rate will indicate that further study would be warranted
Using alfa and beta errors of 010 if an objective response is observed in at least 1 of the 12 patients enrolled during the first stage the study will go on with a
Step 2 recruitment of an additional 25 patients The treatments will be considered active if an objective response is observed in 4 out of 37 patients treated
The enrolment period will be 24 months To ensure patients safety a continued safety evaluation by an independent DSMB will be performed and formal rules will be planned to continue or stop the recruitment in particular the enrollment will be interrupted when six patients completed at least one cycle of the combo treatment and they will be evaluated for safety if grade 3 AEs except for fever and rash that will be consider only for grade 4 in 2 two or more patients will be observed within 30 days after completion of the first dose of combo treatment the study will be interrupted
Secondary end points
1 Toxicity
2 Overall Survival
3 Duration of response
4 PFS
5 ORR by RECIST 11
6 Prognostic and predictive marker response
7 Immunological response Study Product Dose Route Regimen and duration of administration Three daily doses boost radiotherapy XRT at 6-12 Gy to at least 1 and up to a maximum of 5 metastatic fields will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccineIL-2 The first day of administration of vaccine is day 1 and of IL-2 is day 2
The intradermal autologous dendritic cell vaccine loaded with autologous tumor homogenate plus IL-2 dose 18 MIUm2day in 500cc by continuous IV infusion for 72 hours will be administered every 3 weeks up to 6 cycles
Statistical Methodology
This is a Proof of Principle trial with a minimax two stage design
Step 1 12 patients enrolled A 5 response rate will preclude further study whereas a 20 response rate will indicate that further study would be warranted
Using alfa and beta errors of 010 if an objective response is observed in at least 1 of the 12 patients enrolled during the first stage the study will go on with a
Step 2 recruitment of an additional 25 patients The treatments will be considered active if an objective response is observed in 4 out of 37 patients treated
The enrolment period will be 24 months To ensure patients safety a continued safety evaluation by an independent DSMB will be performed and formal rules will be planned to continue or stop the recruitment in particular the enrollment will be interrupted when six patients completed at least one cycle of the combo treatment and they will be evaluated for safety if grade 3 AEs except for fever and rash that will be consider only for grade 4 in 2 two or more patients will be observed within 30 days after completion of the first dose of combo treatment the study will be interrupted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-000556-14 | EUDRACT_NUMBER | None | None |