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Peptide-specific Vaccination in HLA-A*02 Positive Patients With Biochemical Recurrence After Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02452307
Recruitment Status : Unknown
Verified August 2017 by University Hospital Tuebingen.
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2015
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Cancer Biological: Peptide vaccine Drug: Montanide ISA-51 Drug: Granulocyte macrophage colony stimulating factor (GM-CSF) Drug: Imiquimod Drug: mRNA Drug: Protamin Procedure: local hyperthermia Phase 1 Phase 2

Detailed Description:
Patients with a biochemical recurrence after initial therapy can be included.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Peptide-specific Vaccination in HLA-A*02 Positive Prostate Carcinoma Patients With Biochemical Recurrence After Radical Prostatectomy
Study Start Date : April 2004
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peptide vaccine
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
Biological: Peptide vaccine
subcutaneous

Drug: Montanide ISA-51
subcutaneous

Experimental: Peptide vaccine + GM-CSF
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
Biological: Peptide vaccine
subcutaneous

Drug: Montanide ISA-51
subcutaneous

Drug: Granulocyte macrophage colony stimulating factor (GM-CSF)
intradermal

Experimental: Peptide vaccine + local hyperthermia
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Biological: Peptide vaccine
subcutaneous

Drug: Montanide ISA-51
subcutaneous

Procedure: local hyperthermia
Experimental: Peptide vaccine + Imiquimod
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
Biological: Peptide vaccine
subcutaneous

Drug: Montanide ISA-51
subcutaneous

Drug: Imiquimod
epicutaneous

Experimental: Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Biological: Peptide vaccine
subcutaneous

Drug: Montanide ISA-51
subcutaneous

Drug: mRNA
subcutaneous

Drug: Protamin
subcutaneous




Primary Outcome Measures :
  1. Change from Baseline in Immune Response at day 70 [ Time Frame: Days 0-70 ]
    Immune Response, as measured by the change of in vitro and in vivo T cell response from baseline at day 0 to day 70


Secondary Outcome Measures :
  1. Tolerability [ Time Frame: Days 0-420 ]
    Tolerability, as measured by number of Participants with Adverse Events

  2. Treatment response [ Time Frame: Months 0-60 ]
    Treatment response, from date of randomization until the date of first documented progression as measured by PSA-value



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452307


Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Arnulf Stenzl, Prof. Department of Urology, University of Tuebingen
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02452307    
Other Study ID Numbers: 167/2003
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Imiquimod
Molgramostim
Protamines
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antineoplastic Agents
Interferon Inducers
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants