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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2018-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Renal Cell Cancer Advanced Renal Cell Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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)

Group Type EXPERIMENTAL

peptide vaccine

Intervention Type BIOLOGICAL

subcutaneous

Granulocyte Macrophage Colony Stimulating Factor

Intervention Type DRUG

intradermal

Study Arm 2

Intradermal application of peptide vaccine with Montanide ISA-51

Group Type ACTIVE_COMPARATOR

peptide vaccine

Intervention Type BIOLOGICAL

subcutaneous

Montanide ISA-51

Intervention Type DRUG

subcutaneous

Interventions

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peptide vaccine

subcutaneous

Intervention Type BIOLOGICAL

Granulocyte Macrophage Colony Stimulating Factor

intradermal

Intervention Type DRUG

Montanide ISA-51

subcutaneous

Intervention Type DRUG

Other Intervention Names

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GM-CSF

Eligibility Criteria

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Inclusion Criteria

* Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
* 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

* detectable distant metastasis in radiological imaging (M1)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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