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, Elisabeth M. Paietta, Ellen R. Gaynor, David H. Boldt, James H. Doroshow, Frederick R. Aronson

Research output: Contribution to journalArticle

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Abstract

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 10<sup>10</sup>, 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
Volume15
Issue number1
StatePublished - 1994

Fingerprint

Lymphokine-Activated Killer Cells
Phase II Clinical Trials
Interleukin-2
Colorectal Neoplasms
Leukapheresis
Lymphokines
Therapeutics
Intravenous Infusions
Immunotherapy
Weight Gain
Intensive Care Units
Anemia
Creatinine
Radiotherapy
Confidence Intervals
Drug Therapy
Liver
Enzymes

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Immunology
  • Immunology and Allergy
  • Pharmacology

Cite this

Hawkins, M. J., Atkins, M. B., Dutcher, J. P., Fisher, R. I., Weiss, G. R., Margolin, K. A., ... Aronson, F. R. (1994). A Phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma. Journal of Immunotherapy, 15(1), 74-78.

A Phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma. / Hawkins, Michael J.; Atkins, Michael B.; Dutcher, Janice P.; Fisher, Richard I.; Weiss, Geoffrey R.; Margolin, Kim A.; Rayner, Anthony A.; Sznol, Mario; Parkinson, David R.; Paietta, Elisabeth M.; Gaynor, Ellen R.; Boldt, David H.; Doroshow, James H.; Aronson, Frederick R.

In: Journal of Immunotherapy, Vol. 15, No. 1, 1994, p. 74-78.

Research output: Contribution to journalArticle

Hawkins, MJ, Atkins, MB, Dutcher, JP, Fisher, RI, Weiss, GR, Margolin, KA, Rayner, AA, Sznol, M, Parkinson, DR, Paietta, EM, Gaynor, ER, Boldt, DH, Doroshow, JH & Aronson, FR 1994, 'A Phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma', Journal of Immunotherapy, vol. 15, no. 1, pp. 74-78.
Hawkins MJ, Atkins MB, Dutcher JP, Fisher RI, Weiss GR, Margolin KA et al. A Phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma. Journal of Immunotherapy. 1994;15(1):74-78.
Hawkins, Michael J. ; Atkins, Michael B. ; Dutcher, Janice P. ; Fisher, Richard I. ; Weiss, Geoffrey R. ; Margolin, Kim A. ; Rayner, Anthony A. ; Sznol, Mario ; Parkinson, David R. ; Paietta, Elisabeth M. ; Gaynor, Ellen R. ; Boldt, David H. ; Doroshow, James H. ; Aronson, Frederick R. / A Phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma. In: Journal of Immunotherapy. 1994 ; Vol. 15, No. 1. pp. 74-78.
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T1 - A Phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma

AU - Hawkins, Michael J.

AU - Atkins, Michael B.

AU - Dutcher, Janice P.

AU - Fisher, Richard I.

AU - Weiss, Geoffrey R.

AU - Margolin, Kim A.

AU - Rayner, Anthony A.

AU - Sznol, Mario

AU - Parkinson, David R.

AU - Paietta, Elisabeth M.

AU - Gaynor, Ellen R.

AU - Boldt, David H.

AU - Doroshow, James H.

AU - Aronson, Frederick R.

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N2 - 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.

AB - 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.

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