Back to resultsAdjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides (UroRCC)
Primary Purpose
Renal Cell Cancer, Advanced Renal Cell Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
peptide vaccine
Granulocyte Macrophage Colony Stimulating Factor
Montanide ISA-51
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Cancer
Eligibility Criteria
Inclusion Criteria:
- Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
- N+, M0
- M1 (after complete metastasectomy)
- ECOG performance status 0 or 1
- age >18 years
- at least 4 weeks since last administration of radiation- or chemotherapy
- Serum levels of bilirubin <2 mg/dl, creatinine<2mg/dl
Exclusion Criteria:
- detectable distant metastasis in radiological imaging (M1)
- patients unable to consent
- severe cardiopulmonary disorder (NYHA >= 3)
- presence of secondary malignancy
- Immunosuppressive medication (last application of glucocorticoids > 4 weeks)
- seizure
- pregnancy
- simultaneous participation in other active or passive immunisation treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Arm 1
Study Arm 2
Arm Description
Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Intradermal application of peptide vaccine with Montanide ISA-51
Outcomes
Primary Outcome Measures
Tolerability
Tolerability, as measured by number of Participants with Adverse Events
Secondary Outcome Measures
All Cause Mortality
All cause Mortality, as measured as length of Overall Survival
Progression-free Survival
Progression-free Survival, as measured as time to radiographic progression
Immune Response
Immune Response, as as measured by in vitro and in vivo T cell response on day 0 and day 70. In selected cases additional immune response evaluation might be applicable.
Full Information
NCT ID
NCT02429440
First Posted
April 14, 2015
Last Updated
August 14, 2017
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02429440
Brief Title
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
Acronym
UroRCC
Official Title
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Cancer, Advanced Renal Cell Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Arm 1
Arm Type
Experimental
Arm Description
Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Arm Title
Study Arm 2
Arm Type
Active Comparator
Arm Description
Intradermal application of peptide vaccine with Montanide ISA-51
Intervention Type
Biological
Intervention Name(s)
peptide vaccine
Intervention Description
subcutaneous
Intervention Type
Drug
Intervention Name(s)
Granulocyte Macrophage Colony Stimulating Factor
Other Intervention Name(s)
GM-CSF
Intervention Description
intradermal
Intervention Type
Drug
Intervention Name(s)
Montanide ISA-51
Intervention Description
subcutaneous
Primary Outcome Measure Information:
Title
Tolerability
Description
Tolerability, as measured by number of Participants with Adverse Events
Time Frame
Day 0-365
Secondary Outcome Measure Information:
Title
All Cause Mortality
Description
All cause Mortality, as measured as length of Overall Survival
Time Frame
60 Months
Title
Progression-free Survival
Description
Progression-free Survival, as measured as time to radiographic progression
Time Frame
36 Months
Title
Immune Response
Description
Immune Response, as as measured by in vitro and in vivo T cell response on day 0 and day 70. In selected cases additional immune response evaluation might be applicable.
Time Frame
Day 0-365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
N+, M0
M1 (after complete metastasectomy)
ECOG performance status 0 or 1
age >18 years
at least 4 weeks since last administration of radiation- or chemotherapy
Serum levels of bilirubin <2 mg/dl, creatinine<2mg/dl
Exclusion Criteria:
detectable distant metastasis in radiological imaging (M1)
patients unable to consent
severe cardiopulmonary disorder (NYHA >= 3)
presence of secondary malignancy
Immunosuppressive medication (last application of glucocorticoids > 4 weeks)
seizure
pregnancy
simultaneous participation in other active or passive immunisation treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnulf Stenzl, Prof.
Organizational Affiliation
University of Tübingen, Department of Urology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
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