Prospective Randomized Trial of Peptide-specific Vaccination in HLA-A*02 Positive Prostate Carcinoma Patients With Biochemical Recurrence After Radical Prostatectomy
Overview
- Phase
- Phase 1
- Intervention
- Peptide vaccine
- Conditions
- Recurrent Prostate Cancer
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 36
- Primary Endpoint
- Change from Baseline in Immune Response at day 70
- Last Updated
- 8 years ago
Overview
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.
Detailed Description
Patients with a biochemical recurrence after initial therapy can be included.
Investigators
Eligibility 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
Arms & Interventions
Peptide vaccine
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
Intervention: Peptide vaccine
Peptide vaccine
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
Intervention: Montanide ISA-51
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)
Intervention: Peptide vaccine
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)
Intervention: Montanide ISA-51
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)
Intervention: Granulocyte macrophage colony stimulating factor (GM-CSF)
Peptide vaccine + local hyperthermia
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Intervention: Peptide vaccine
Peptide vaccine + local hyperthermia
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Intervention: Montanide ISA-51
Peptide vaccine + local hyperthermia
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Intervention: local hyperthermia
Peptide vaccine + Imiquimod
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
Intervention: Peptide vaccine
Peptide vaccine + Imiquimod
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
Intervention: Montanide ISA-51
Peptide vaccine + Imiquimod
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
Intervention: Imiquimod
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Intervention: Peptide vaccine
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Intervention: Montanide ISA-51
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Intervention: mRNA
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Intervention: Protamin
Outcomes
Primary Outcomes
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 Outcomes
- Tolerability(Days 0-420)
- Treatment response(Months 0-60)