Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
NCT ID: NCT02429440
Last Updated: 2017-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2005-05-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study Arm 1
Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
peptide vaccine
subcutaneous
Granulocyte Macrophage Colony Stimulating Factor
intradermal
Study Arm 2
Intradermal application of peptide vaccine with Montanide ISA-51
peptide vaccine
subcutaneous
Montanide ISA-51
subcutaneous
Interventions
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peptide vaccine
subcutaneous
Granulocyte Macrophage Colony Stimulating Factor
intradermal
Montanide ISA-51
subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Arnulf Stenzl, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Tübingen, Department of Urology
Other Identifiers
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231/2004
Identifier Type: -
Identifier Source: org_study_id
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