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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02429440
Other study ID # 231/2004
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received April 14, 2015
Last updated August 14, 2017
Start date May 2005
Est. completion date June 2018

Study information

Verified date August 2017
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date June 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
peptide vaccine
subcutaneous
Drug:
Granulocyte Macrophage Colony Stimulating Factor
intradermal
Montanide ISA-51
subcutaneous

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability Tolerability, as measured by number of Participants with Adverse Events Day 0-365
Secondary All Cause Mortality All cause Mortality, as measured as length of Overall Survival 60 Months
Secondary Progression-free Survival Progression-free Survival, as measured as time to radiographic progression 36 Months
Secondary 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
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