Carcinoma, Renal Cell Clinical Trial
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)
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 vaccine+IL-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 MIU/m2/day 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).
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 1.1
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 vaccine+IL-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 MIU/m2/day 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 0.10, 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.
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