Carcinoma, Renal CellPhase 2RENALVax-2NCT03226236
Vaccination With Dendritic Cells Pulsed With Autologous Tumor Homogenate in Combination With HD-IL2 and Immunomodulating Radiotherapy in Metastatic RCC
A Phase 2 study testing boost radiotherapy (XRT), Autologous DC vaccine and High-Dose IL-2 in people with Carcinoma, Renal Cell and Vaccination, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial 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 vaccine+IL-2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Vaccination, Secondary
- What is being tested?
- boost radiotherapy (XRT), Autologous DC vaccine and High-Dose IL-2
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Written Informed Consent: patients must be willing and able to give written informed consent, that have to be given before starting of screening procedure.
- Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the "Product Specification File".
- Patients must have histologically or cytologically confirmed RCC (all histology types except for urothelial cancer);
- Patients must have stage IV disease in progression after at least 1 TKI and/or antiangiogenetic and/or mTOR inhibitors therapy (patients must have finished prior treatments at least 4 weeks before the first IL2 dose)
- Patients must have at least one measurable lesion, according to the irRC response criteria (see section 8 ), after asportation of tumor tissue for vaccine preparation. The tumor lesions that will be irradiated are excluded for response evaluation.
- Life expectancy of greater than 3 months.
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- ECOG performance status 0-1
- Patients must have organ and marrow function as defined below:
- leukocytes >4000/µL
- absolute neutrophil count >1,500/µL
- platelets >100,000/µL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- creatinine < 1.5 mg/dl
- haemoglobin >8.0 gm/dl
- hematocrit <30%
- ECG and echocardiogram within normal institutional limits
- Pulmonary function tests within normal institutional limits (to be performed only in patients with lung metastases or history of impaired lung function)
- No contraindication for the use of vasopressor agents
- Negative screening tests for HIV, HBV HCV and syphilis not older than 30 days before performing any of the GMP-regulated activities required (leukapheresis, collection of tumor biopsies to be used for tumor homogenate preparation);
- Men and women aged > 18 years.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up 8 weeks after the study, in order to minimize the risk of pregnancy;
- Patients must have normal organ and marrow function according to clinical practice.
Who cannot join
- Patients who have positive tests to HCV, HBV, HIV, or syphilis (specific blood testing must be performed within 30 days before any GMP-regulated activity (leukapheresis and collection of tumor biopsies to be used for tumor homogenate preparation).
- Patients who did not have prior lines of systemic therapy for advanced disease.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (on physician's judgment).
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
- Patients who have had chemotherapy or radiotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
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- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in the study.
- Any autoimmune disease which could be exacerbated by IL-2
- A medical illness requiring chronic treatments with corticosteroids or other immunosuppressive agents
- A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac arrhythmias, angina pectoris or cerebrovascular accident
- HIV-positivity, whether or not symptomatic
- Any contraindication to undergo leukapheresis as evaluated by transfusionist (e.g. severe anemia, piastrinopenia, oral anticoagulant therapy) or to undergo surgery.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UO Immunoterapia e Laboratorio TCS, IRCCS IRST
Meldola (FC), FC, 47014
About this study
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.
Read more
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).
Read the 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:
- Toxicity
- Overall Survival
- Duration of response
- PFS
- ORR by RECIST 1.1
- Prognostic and predictive marker response
- 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.
- Conditions
- Carcinoma, Renal Cell, Vaccination, Secondary
- Being tested
- boost radiotherapy (XRT), Autologous DC vaccine, High-Dose IL-2
- Keywords
- Carcinoma, Renal Cell, vaccination, dendritic cells, autologous tumor homogenate, High Dose -IL2, immunomodulating radiotherapy, secondary
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
boost radiotherapy (XRT)Radiation
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
Autologous DC vaccineBiological
The first dose (7 to 14 x 10_6 total dendritic cells) will be performed with freshly prepared vaccine, 9 days after leukapheresis; on day +1 starting from cycle 2 (3 weeks after the first cycle, on completion of QA assessments on the cryopreserved products), 5 additional doses will be administered every 3 weeks until maximum six vaccines.
High-Dose IL-2Drug
high dose IL-2: 18 MIU/m2/day in 500cc administered by continuous IV infusion for 72 hours starting day +2.
| Study group | Role | What they receive |
|---|---|---|
| study treatment | Experimental | boost radiotherapy (XRT) plus intradermal autologous dendritic cell vaccine loaded with autologous tumor homogenate (Autologous DC vaccine) plus High-Dose IL-2 Receives: Radiation: boost radiotherapy (XRT); Biological: Autologous DC vaccine; Drug: High-Dose IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) by Immune related Response Criteria( irRC)
The analysis will be performed on an intention to treat population, i.e. all patients having received at least 2 cycles of therapy.
Measured: up to 24 months
Secondary outcomes (5)
Overall survival (OS)
measured from the date of registration until the date of death from any cause or the last date the patient was known to be alive and will be estimated with Kaplan-Meier method and the log rank test
Measured: up to 24 months
Duration of response
time calculated from documentation of tumor response to disease progression
Measured: up to 24 months
Progression free survival
measured from registration until disease progression or death
Measured: up to 24 months
Immunologic efficacy
Immunologic efficacy will be measured by best DTH score (reactivity to homogenate or KLH) obtained after at least 4 vaccine doses, alone or combined with IFN-g ELISPOT analysis of tumor antigen-specific circulating effectors obtained after a minimum of 4 vaccine doses, both compared with prevaccine samples
Measured: up to 24 months
Adverse events evaluation
Number of patients with treatment related Adverse events (AE) will be evaluated by CTCAE v 4.03 criteria The percentage of patients reporting an AE up to 30 days after HD-IL-2 treatment will be tabulated with 95% confidence intervals, by type of AE. The overall rate of grade 3-4 related AE will be computed
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startMar 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: No patients enrolled due to change in standard practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Ridolfi, MD, Principal investigator, UO Immunoterapia e Laboratorio TCS, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226236
- Sponsor's protocol ID
- IRST189.03
- Other IDs
- 2015-000556-14, 2015
- Acronym
- RENALVax-2
- Status last verified
- Nov 2018
- First submitted
- 28 Sep 2016
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03226236
- Acronym / sponsor ID
- RENALVax-2 / IRST189.03
- Conditions
- Carcinoma, Renal Cell, Vaccination, Secondary
- Keywords
- Carcinoma, Renal Cell, vaccination, dendritic cells, autologous tumor homogenate, High Dose -IL2, immunomodulating radiotherapy, secondary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled due to change in standard practice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- Toxicity
- Overall Survival
- Duration of response
- PFS
- ORR by RECIST 1.1
- Prognostic and predictive marker response
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study treatment | Experimental | Radiation: boost radiotherapy (XRT), Biological: Autologous DC vaccine, Drug: High-Dose IL-2boost radiotherapy (XRT) plus intradermal autologous dendritic cell vaccine loaded with autologous tumor homogenate (Autologous DC vaccine) plus High-Dose IL-2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Signed Written Informed Consent: patients must be willing and able to give written informed consent, that have to be given before starting of screening procedure.
- Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the "Product Specification File".
- Patients must have histologically or cytologically confirmed RCC (all histology types except for urothelial cancer);
- Patients must have stage IV disease in progression after at least 1 TKI and/or antiangiogenetic and/or mTOR inhibitors therapy (patients must have finished prior treatments at least 4 weeks before the first IL2 dose)
- Patients must have at least one measurable lesion, according to the irRC response criteria (see section 8 ), after asportation of tumor tissue for vaccine preparation. The tumor lesions that will be irradiated are excluded for response evaluation.
Key exclusion criteria (13 listed)
- Patients who have positive tests to HCV, HBV, HIV, or syphilis (specific blood testing must be performed within 30 days before any GMP-regulated activity (leukapheresis and collection of tumor biopsies to be used for tumor homogenate preparation).
- Patients who did not have prior lines of systemic therapy for advanced disease.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (on physician's judgment).
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| boost radiotherapy (XRT)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 | Radiation | study treatment |
| Autologous DC vaccineThe first dose (7 to 14 x 10_6 total dendritic cells) will be performed with freshly prepared vaccine, 9 days after leukapheresis; on day +1 starting from cycle 2 (3 weeks after the first cycle, on completion of QA assessments on the cryopreserved products), 5 additional doses will be administered every 3 weeks until maximum six vaccines. | Biological | study treatment |
| High-Dose IL-2high dose IL-2: 18 MIU/m2/day in 500cc administered by continuous IV infusion for 72 hours starting day +2. | Drug | study treatment |
Primary outcome
Overall Response Rate (ORR) by Immune related Response Criteria( irRC)
Time frame: up to 24 months
The analysis will be performed on an intention to treat population, i.e. all patients having received at least 2 cycles of therapy.
5 secondary outcomes
Overall survival (OS)
Time frame: up to 24 months
Duration of response
Time frame: up to 24 months
Progression free survival
Time frame: up to 24 months
Immunologic efficacy
Time frame: up to 24 months
Adverse events evaluation
Time frame: up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Ridolfi, MD principal investigator
UO Immunoterapia e Laboratorio TCS, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing boost radiotherapy (XRT), Autologous DC vaccine and High-Dose IL-2 in people with Carcinoma, Renal Cell and Vaccination, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) by Immune related Response Criteria( irRC) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.