Phase ii trials of high-dose interleukin-2 and lymphokine-activated killer cells in advanced breast carcinoma and carcinoma of the lung, ovary, and pancreas and other tumors

Joseph A. Sparano, Richard I. Fisher, Geoffrey R. Weiss, Kim Margolin, Frederick R. Aronson, Michael J. Hawkins, Michael B. Atkins, Janice P. Dutcher, Ellen R. Gaynor, David H. Boldt, James H. Doroshow, Mary Lou Ernest, Mario Sznol, James W. Mier

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Summary: Treatment with interleukin-2 (IL-2) used alone or in combination with lymphokine-activated killer (LAK) cells is known to be an active therapy for patients with advanced renal cell carcinoma and melanoma. To further explore the activity of IL-2/LAK cell therapy in patients with advanced cancer of various primary sites, the Extramural IL-2/LAK Working Group (ILWG) initiated two phase II trials of high-dose IL-2/LAK therapy: One in patients with advanced breast carcinoma, and one in patients with advanced cancer arising in other sites. Patients with advanced renal cell carcinoma, melanoma, colorectal carcinoma, and lymphoma (Hodgkin’s and B-cell non-Hodgkin’s) were not eligible for the latter trial, but were treated on other ILWG trials that have been reported previously. Sixty-nine patients received high-dose IL-2 (600,000 IU/kg administered by a 15-min intravenous infusion every 8 h) on days 1-5 and days 11-15. Leukapheresis was performed for collection and ex vivo expansion of LAK cells on days 7-10, and the LAK cells were reinfused on days 11, 12, and 14. The studies were designed to determine whether treatment with IL-2/LAK resulted in at least a 40% response rate, a level of activity that was believed to be sufficient to justify the toxicity and cost of IL-2/LAK therapy. An adequate number of patients with carcinoma of the breast (N = 12), pancreas (N = 8), ovary (N = 7), and lung (non-small cell; N = 6) were accrued to assess response; most of these patients had prior chemotherapy that had failed. In addition, 32 patients with a variety of other tumor types were accrued, but accrual was not adequate to assess response in other primary tumor sites. One patient with adenocarcinoma of the breast had a partial response of 17 weeks’ duration. Two patients had minor tumor regression (adenocarcinoma of the lung and spindle cell sarcoma of the lung). We conclude that high-dose IL-2/LAK is not likely to be associated with a response rate exceeding 40% for patients with carcinomas arising in the breast, pancreas, ovary, and lung (non-small cell).

Original languageEnglish (US)
Pages (from-to)216-223
Number of pages8
JournalJournal of Immunotherapy
Volume16
Issue number3
StatePublished - 1994

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Lymphokine-Activated Killer Cells
Interleukin-2
Pancreas
Ovary
Breast Neoplasms
Carcinoma
Lung
Lymphokines
Neoplasms
Renal Cell Carcinoma
Melanoma
Breast
Leukapheresis
Therapeutics
B-Cell Lymphoma
Cell- and Tissue-Based Therapy
Hodgkin Disease
Intravenous Infusions
Sarcoma
Non-Hodgkin's Lymphoma

Keywords

  • Advanced carcinoma
  • Breast carcinoma
  • Interleukin-2
  • LAK cells
  • Phase II trial

ASJC Scopus subject areas

  • Cancer Research
  • Immunology
  • Immunology and Allergy
  • Pharmacology

Cite this

Phase ii trials of high-dose interleukin-2 and lymphokine-activated killer cells in advanced breast carcinoma and carcinoma of the lung, ovary, and pancreas and other tumors. / Sparano, Joseph A.; Fisher, Richard I.; Weiss, Geoffrey R.; Margolin, Kim; Aronson, Frederick R.; Hawkins, Michael J.; Atkins, Michael B.; Dutcher, Janice P.; Gaynor, Ellen R.; Boldt, David H.; Doroshow, James H.; Ernest, Mary Lou; Sznol, Mario; Mier, James W.

In: Journal of Immunotherapy, Vol. 16, No. 3, 1994, p. 216-223.

Research output: Contribution to journalArticle

Sparano, JA, Fisher, RI, Weiss, GR, Margolin, K, Aronson, FR, Hawkins, MJ, Atkins, MB, Dutcher, JP, Gaynor, ER, Boldt, DH, Doroshow, JH, Ernest, ML, Sznol, M & Mier, JW 1994, 'Phase ii trials of high-dose interleukin-2 and lymphokine-activated killer cells in advanced breast carcinoma and carcinoma of the lung, ovary, and pancreas and other tumors', Journal of Immunotherapy, vol. 16, no. 3, pp. 216-223.
Sparano, Joseph A. ; Fisher, Richard I. ; Weiss, Geoffrey R. ; Margolin, Kim ; Aronson, Frederick R. ; Hawkins, Michael J. ; Atkins, Michael B. ; Dutcher, Janice P. ; Gaynor, Ellen R. ; Boldt, David H. ; Doroshow, James H. ; Ernest, Mary Lou ; Sznol, Mario ; Mier, James W. / Phase ii trials of high-dose interleukin-2 and lymphokine-activated killer cells in advanced breast carcinoma and carcinoma of the lung, ovary, and pancreas and other tumors. In: Journal of Immunotherapy. 1994 ; Vol. 16, No. 3. pp. 216-223.
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AU - Sparano, Joseph A.

AU - Fisher, Richard I.

AU - Weiss, Geoffrey R.

AU - Margolin, Kim

AU - Aronson, Frederick R.

AU - Hawkins, Michael J.

AU - Atkins, Michael B.

AU - Dutcher, Janice P.

AU - Gaynor, Ellen R.

AU - Boldt, David H.

AU - Doroshow, James H.

AU - Ernest, Mary Lou

AU - Sznol, Mario

AU - Mier, James W.

PY - 1994

Y1 - 1994

N2 - Summary: Treatment with interleukin-2 (IL-2) used alone or in combination with lymphokine-activated killer (LAK) cells is known to be an active therapy for patients with advanced renal cell carcinoma and melanoma. To further explore the activity of IL-2/LAK cell therapy in patients with advanced cancer of various primary sites, the Extramural IL-2/LAK Working Group (ILWG) initiated two phase II trials of high-dose IL-2/LAK therapy: One in patients with advanced breast carcinoma, and one in patients with advanced cancer arising in other sites. Patients with advanced renal cell carcinoma, melanoma, colorectal carcinoma, and lymphoma (Hodgkin’s and B-cell non-Hodgkin’s) were not eligible for the latter trial, but were treated on other ILWG trials that have been reported previously. Sixty-nine patients received high-dose IL-2 (600,000 IU/kg administered by a 15-min intravenous infusion every 8 h) on days 1-5 and days 11-15. Leukapheresis was performed for collection and ex vivo expansion of LAK cells on days 7-10, and the LAK cells were reinfused on days 11, 12, and 14. The studies were designed to determine whether treatment with IL-2/LAK resulted in at least a 40% response rate, a level of activity that was believed to be sufficient to justify the toxicity and cost of IL-2/LAK therapy. An adequate number of patients with carcinoma of the breast (N = 12), pancreas (N = 8), ovary (N = 7), and lung (non-small cell; N = 6) were accrued to assess response; most of these patients had prior chemotherapy that had failed. In addition, 32 patients with a variety of other tumor types were accrued, but accrual was not adequate to assess response in other primary tumor sites. One patient with adenocarcinoma of the breast had a partial response of 17 weeks’ duration. Two patients had minor tumor regression (adenocarcinoma of the lung and spindle cell sarcoma of the lung). We conclude that high-dose IL-2/LAK is not likely to be associated with a response rate exceeding 40% for patients with carcinomas arising in the breast, pancreas, ovary, and lung (non-small cell).

AB - Summary: Treatment with interleukin-2 (IL-2) used alone or in combination with lymphokine-activated killer (LAK) cells is known to be an active therapy for patients with advanced renal cell carcinoma and melanoma. To further explore the activity of IL-2/LAK cell therapy in patients with advanced cancer of various primary sites, the Extramural IL-2/LAK Working Group (ILWG) initiated two phase II trials of high-dose IL-2/LAK therapy: One in patients with advanced breast carcinoma, and one in patients with advanced cancer arising in other sites. Patients with advanced renal cell carcinoma, melanoma, colorectal carcinoma, and lymphoma (Hodgkin’s and B-cell non-Hodgkin’s) were not eligible for the latter trial, but were treated on other ILWG trials that have been reported previously. Sixty-nine patients received high-dose IL-2 (600,000 IU/kg administered by a 15-min intravenous infusion every 8 h) on days 1-5 and days 11-15. Leukapheresis was performed for collection and ex vivo expansion of LAK cells on days 7-10, and the LAK cells were reinfused on days 11, 12, and 14. The studies were designed to determine whether treatment with IL-2/LAK resulted in at least a 40% response rate, a level of activity that was believed to be sufficient to justify the toxicity and cost of IL-2/LAK therapy. An adequate number of patients with carcinoma of the breast (N = 12), pancreas (N = 8), ovary (N = 7), and lung (non-small cell; N = 6) were accrued to assess response; most of these patients had prior chemotherapy that had failed. In addition, 32 patients with a variety of other tumor types were accrued, but accrual was not adequate to assess response in other primary tumor sites. One patient with adenocarcinoma of the breast had a partial response of 17 weeks’ duration. Two patients had minor tumor regression (adenocarcinoma of the lung and spindle cell sarcoma of the lung). We conclude that high-dose IL-2/LAK is not likely to be associated with a response rate exceeding 40% for patients with carcinomas arising in the breast, pancreas, ovary, and lung (non-small cell).

KW - Advanced carcinoma

KW - Breast carcinoma

KW - Interleukin-2

KW - LAK cells

KW - Phase II trial

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