Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Freund's Adjuvant; Molgramostim; Sargramostim; Vaccines

Criteria

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