Renal Cell Cancer, Advanced Renal Cell Cancer
Conditions
Brief 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).
Interventions
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability | Day 0-365 | Tolerability, as measured by number of Participants with Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | 60 Months | All cause Mortality, as measured as length of Overall Survival |
| Progression-free Survival | 36 Months | Progression-free Survival, as measured as time to radiographic progression |
| Immune Response | Day 0-365 | 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. |
Outcome results
None listed