Overview

This trial is active, not recruiting.

Condition recurrent prostate cancer
Treatments peptide vaccine, montanide isa-51, granulocyte macrophage colony stimulating factor (gm-csf), imiquimod, mrna, protamin, local hyperthermia
Phase phase 1/phase 2
Sponsor University Hospital Tuebingen
Start date April 2004
End date January 2015
Trial size 36 participants
Trial identifier NCT02452307, 167/2003

Summary

The study evaluates the prostate-specific antigen (PSA) response in HLA-A*02 positive patients with biochemical recurrence after radical prostatectomy treated with a prostate-specific peptide vaccine in combination with different immune-adjuvants.

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)
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
peptide vaccine
subcutaneous
montanide isa-51
subcutaneous
(Experimental)
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
peptide vaccine
subcutaneous
montanide isa-51
subcutaneous
granulocyte macrophage colony stimulating factor (gm-csf)
intradermal
(Experimental)
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
peptide vaccine
subcutaneous
montanide isa-51
subcutaneous
local hyperthermia
(Experimental)
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
peptide vaccine
subcutaneous
montanide isa-51
subcutaneous
imiquimod
epicutaneous
(Experimental)
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
peptide vaccine
subcutaneous
montanide isa-51
subcutaneous
mrna
subcutaneous
protamin
subcutaneous

Primary Outcomes

Measure
Change from Baseline in Immune Response at day 70
time frame: Days 0-70

Secondary Outcomes

Measure
Tolerability
time frame: Days 0-420
Treatment response
time frame: Months 0-60

Eligibility Criteria

Male participants from 45 years up to 80 years old.

Inclusion Criteria: - biochemical recurrence after Radical Prostatectomy - no clinical metastases in CT or bone scan - HLA-Type: HLA-A*02 positive - Karnofsky-Performance-Index >70 - Age >45 / <80 years - no prior or ongoing hormonal therapy - no ongoing radiation therapy - Serum-Creatinine <2mg/dl; Bilirubin: <2gm/dl - no history of allergy or chronic obstructive lung disease (COLD) Exclusion Criteria: - Patients unable to consent - Karnofsky-Performance-Index <70 - known allergy or COLD - presence of secondary malignancy - prior or ongoing hormonal treatment - ongoing radiotherapy - immunosuppressive medication - seizure

Additional Information

Official title Prospective Randomized Trial of Peptide-specific Vaccination in HLA-A*02 Positive Prostate Carcinoma Patients With Biochemical Recurrence After Radical Prostatectomy
Principal investigator Arnulf Stenzl, Prof.
Description Patients with a biochemical recurrence after initial therapy can be included.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.