Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides (UroRCC)

August 14, 2017 updated by: University Hospital Tuebingen
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm 1
Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Biological: peptide vaccine
subcutaneous
Drug: Granulocyte Macrophage Colony Stimulating Factor
intradermal
Other Names:
  • GM-CSF
Active Comparator: Study Arm 2
Intradermal application of peptide vaccine with Montanide ISA-51
Drug: Montanide ISA-51
subcutaneous
Biological: peptide vaccine
subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability
Time Frame: Day 0-365
Tolerability, as measured by number of Participants with Adverse Events
Day 0-365

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause Mortality
Time Frame: 60 Months
All cause Mortality, as measured as length of Overall Survival
60 Months
Progression-free Survival
Time Frame: 36 Months
Progression-free Survival, as measured as time to radiographic progression
36 Months
Immune Response
Time Frame: Day 0-365
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.
Day 0-365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Arnulf Stenzl, Prof., University of Tübingen, Department of Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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