Phase I study of a gene modified, B7/IL-7-transfected allogeneic tumor cell vaccine for the treatment of metastatic renal cell carcinoma

Phase 1

• Conditions: C64; Malignant neoplasm of kidney, except renal pelvis

• Registration Number: DRKS00000294
• Lead Sponsor: Medizinische Klinik für Hämatologie, Onkologie Charité, Campus Virchow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

histologically proven renal cell carcinoma
-age between 18 and 75
-HLA-A0201-positive patients
-adequate performance status
-life expectancy over 3 months
-interval to last therapy >4 weeks
-one evaluable marker lesion
-written informed consent

Exclusion Criteria

-pregnancy oder nursing, missing contraception
-evidence of autoimmune disease
-history of severe allergy
-systemic corticosteroid therapy or other immunosuppressive therapy
-patients with organ allografts
-HIV positivity
-active infection or severe disease
-active brain lesions
-impaired renal-, liver - oder hematological function
-evidence or history of malignant disease in the past five years
-use of unapproved biologic agents (mistletoe, live cells)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Feasibility and safety of the vaccination <br>-Assessment of a specific t-cell response<br><br>Acute and long-term toxicity will be assesssed by adverse event reports, clinical evaluation and review of laboratoray studies and immunological parameters.<br>The t cell response will be assessed by T cell receptor analysis, ELISPOT assay.

Secondary Outcome Measures

Name	Time	Method
-Clinical outcome<br><br>Clinical outcome will be assessed by clinical examination and CT scans at fixed timepoints.