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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm 1 | Experimental | Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) |
|
| Study Arm 2 | Active Comparator | Intradermal application of peptide vaccine with Montanide ISA-51 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peptide vaccine | Biological | subcutaneous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | Tolerability, as measured by number of Participants with Adverse Events | Day 0-365 |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | All cause Mortality, as measured as length of Overall Survival | 60 Months |
| Progression-free Survival | Progression-free Survival, as measured as time to radiographic progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnulf Stenzl, Prof. | University of Tübingen, Department of Urology | Principal Investigator |
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| Granulocyte Macrophage Colony Stimulating Factor |
| Drug |
intradermal |
|
|
| Montanide ISA-51 | Drug | subcutaneous |
|
| 36 Months |
| Immune Response | 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 |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000096202 | Protein Subunit Vaccines |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C477385 | montanide ISA 51 |
| ID | Term |
|---|---|
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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