A Phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma

Michael J. Hawkins, Michael B. Atkins, Janice P. Dutcher, Richard I. Fisher, Geoffrey R. Weiss, Kim A. Margolin, Anthony A. Rayner, Mario Sznol, David R. Parkinson, Elizabeth Paietta, Ellen R. Gaynor, David H. Boldt, James H. Doroshow, Frederick R. Aronson

Research output: Contribution to journalArticlepeer-review

28 Scopus citations


Summary: Patients (n=22) with metastatic or unresectable colorectal carcinoma were treated with interleukin (IL)-2 and lymphokine-activated killer (LAK) cells in a phase II study conducted by the IL-2/LAK Working Group (ILWG). Eligilbility criteria for the study included bidimensionally measurable disease, performance status 0 or 1, and normal function of all vital organs. The median age of patients was 49 (range, 28–61)years. Eight (36%) patients had never received prior radiotherapy, and 12 (55%) chemotherapy. No patients had received prior immunotherapy. Treatment consisted of Il-2, 600,000 IU/kg administered lby 15 min intravenous infusion every 8 h on days 1–5 and 12–16. Patients underwent 4-h leukapheresis on days 8–12, and cells were placed in in vitro culture with IL-2 for 3–4 days and the activated LAK cells were infused over 1 h on days 12, 13, and 15. All doses of IL-2 and LAK cells were administered to patients in intensive care unit (ICU) settings. The mean ± SD number of IL-2 doses administered during days 1–5 was 13.4 ± 1.2, the mean number of LAK cells reinfused was 6.8 ± 2.2 x 1010, and the mean number of IL-2 doses administered during the last phase was 9.8 ± 2.5. Nineteen patients completed the IL-2 priming phase and received at least one LAK cell infusion. One patient achieved a complete response and was progression free for 8 months from the beginning of treatment for an overall objective response rate of 5% (95% confidence interval: 0–13%). Hyp9otension, weight gain, anemia, and elevations of serum creatinine and liver enzymes were common, but there were no treatment-related death. Treatment delivered and tozicity were comparable to lthose reported in studies conducted concurrently for other malignancies. We conclude that high-dose IL-2 with other immunotherapeutic approache.

Original languageEnglish (US)
Pages (from-to)74-78
Number of pages5
JournalJournal of Immunotherapy
Issue number1
StatePublished - Jan 1994


  • Colorectal carcinoma
  • Interleukin-2
  • Lymphokine-activated Killer cells

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology
  • Cancer Research


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