A phase I randomized study of subcutaneous adjuvant IL-2 in combination with an autologous tumor vaccine in patients with advanced renal cell carcinoma

Robert G. Fenton, Ronald G. Steis, Karen Madara, Arnold H. Zea, Augusto C. Ochoa, John Edward Janik, John W. Smith, Barry L. Gause, William H. Sharfman, Walter J. Urba, Michael G. Hanna, Robert L. DeJager, Mark X. Coyne, Robert D. Crouch, Pat Gray, Joy Beveridge, Stephen P. Creekmore, Jon Holmlund, Brendan D. Curti, Mario SznolDan L. Longo

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


We performed a prospective, randomized study to determine whether subcutaneous administration of interleukin-2 (IL-2) in combination with an autologous renal cell vaccine is feasible and can potentiate antitumor immunity. Seventeen patients with metastatic renal cell carcinoma underwent surgical resection with preparation of an autologous tumor cell vaccine. Patients were vaccinated intradermally twice at weekly intervals with 107 irradiated tumor cells plus bacillus Calmette-Guerin, and once with 107 tumor cells alone. Patients were randomized to one of three groups: no adjuvant IL-2, low-dose IL-2 (1.2 × 106 IU/m2), or high-dose IL-2 (1.2 × 107 ILVm2). IL-2 was administered subcutaneously on the day of vaccination and the subsequent 4 days. Immune response was monitored by delayed-type hypersensitivity (DTH) response to tumor cells as compared with normal autologous renal cells. Sixteen of 17 patients received vaccine therapy. Four patients developed cellular immunity specific for autologous tumor cells as measured by DTH responses; two had received no IL-2 and two had received high-dose IL-2. There were two partial responses (PR) noted, both in patients who received high-dose IL-2. One responding patient was DTH(+) and one was negative. A third patient who was DTH(+) after vaccination with no IL-2 had a dramatic PR after receiving IL-2 subcutaneously in a subsequent protocol. Prospective testing of response to recall antigens indicated that only 5 of 12 tested patients were positive, including both clinical responders. These data suggest that subcutaneously administered adjuvant IL-2 does not dramatically augment the immunologic response to autologous renal cell vaccines as determined by the development of tumor-specific DTH response.

Original languageEnglish (US)
Pages (from-to)364-374
Number of pages11
JournalJournal of Immunotherapy
Issue number5
StatePublished - 1996


  • IL-2
  • Immunization
  • Immunotherapy
  • T cell
  • Vaccine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology
  • Cancer Research


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