Phase I trial of a B7-1 (CD80) gene modified autologous tumor cell vaccine in combination with systemic interleukin-2 in patients with metastatic renal cell carcinoma

J Urol. 2002 May;167(5):1995-2000.


Purpose: A reason that the immune system may fail to reject tumors is that T cells encounter tumor antigen derived peptides on the surface of tumor cells in a tolerizing rather than activating context since tumor cells do not express T cell co-stimulatory molecules such as B7-1 (CD80). In preclinical models over expression of B7-1 on the surface of tumor cells has been shown to activate T cells which kill tumor cells. We conducted a phase I clinical trial testing this approach in patients with metastatic renal cell carcinoma.

Materials and methods: Resected tumors from 15 patients were disaggregated and adapted to tissue culture, transduced with the B7-1 gene and injected subcutaneously as a vaccine. The dose of the vaccine was escalated in 3 separate cohorts of patients, and systemic interleukin-2 (IL-2) was administered as an adjuvant designed to enhance the proliferation of the vaccine activated T cells.

Results: Of the 15 patients 9 had measurable disease, 2 had a partial response and 2 had stable disease. Perivascular T cell infiltrates at autologous tumor delayed type hypersensitivity skin test sites developed in 3 of the 4 patients with stable disease or partial response. Although the patients experienced the usual and expected toxicity from the IL-2, there was no significant toxicity observed with the vaccine.

Conclusions: The B7-1 gene modified autologous tumor cell vaccine is safe and can be combined with systemic IL-2 with acceptable toxicity. Immunological and clinical responses were observed in some of the patients. A phase II trial is reasonable to determine the efficacy of this approach.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • B7-1 Antigen / genetics
  • B7-1 Antigen / immunology*
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / immunology
  • Cancer Vaccines / therapeutic use*
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / immunology
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Injections, Intradermal
  • Interleukin-2 / adverse effects
  • Interleukin-2 / immunology
  • Interleukin-2 / therapeutic use*
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / immunology
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Palliative Care
  • T-Lymphocytes / immunology
  • Transfection
  • Tumor Cells, Cultured / immunology
  • Vaccines, DNA / adverse effects
  • Vaccines, DNA / immunology
  • Vaccines, DNA / therapeutic use*


  • B7-1 Antigen
  • Cancer Vaccines
  • Interleukin-2
  • Vaccines, DNA