Overview

This trial is active, not recruiting.

Conditions renal cell cancer, advanced renal cell cancer
Treatments peptide vaccine, granulocyte macrophage colony stimulating factor, montanide isa-51
Phase phase 1/phase 2
Sponsor University Hospital Tuebingen
Start date May 2005
End date October 2014
Trial size 40 participants
Trial identifier NCT02429440, 231/2004

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
peptide vaccine
subcutaneous
granulocyte macrophage colony stimulating factor GM-CSF
intradermal
(Active Comparator)
Intradermal application of peptide vaccine with Montanide ISA-51
peptide vaccine
subcutaneous
montanide isa-51
subcutaneous

Primary Outcomes

Measure
Tolerability
time frame: Day 0-365

Secondary Outcomes

Measure
All Cause Mortality
time frame: 60 Months
Progression-free Survival
time frame: 36 Months
Immune Response
time frame: Day 0-365

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
Principal investigator Arnulf Stenzl, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.