Dendritic Cell Based Therapy of Renal Cell Carcinoma

Inge Marie Svane

Status and phase

Completed

Phase 2

Phase 1

Conditions

Advanced Renal Cell Carcinoma

Treatments

Biological: tumor antigen loaded autologous dendritic cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00197860

UR0414

Details and patient eligibility

About

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable immune response in patients with metastatic renal cell carcinoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

Full description

Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.

HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region. IL-2 2 MIU s.c. day 2-6 and Thymosin alpha 1 (Zadaxin®, SciClone) 1,6 mg s.c. twice a week are used for adjuvants. Scans and re-staging tests are performed at scheduled intervals throughout the study.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven progressive metastatic or locally advanced renal cell carcinoma
No standard treatment indicated
Age: > 18
WHO-Performance Status 0-1
At least tone measurable tumor lesions according to the RECIST criteria.
Life expectancy more than 3 months
Acceptable CBC and blood chemistry results
Written informed consent

Exclusion criteria

Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
Patients with metastatic disease in the central nervous system (CNS).
Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
Patients who are pregnant.
Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
Patients who receive corticosteroids or other immunosuppressive agents.
Baseline serum LDH greater than 4 times the upper limit of normal.
Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.