A phase II clinical trial of interleukin-2 and lymphokine-activated killer cells in advanced colorectal carcinoma.
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). Eligibility criteria for the study included bi-dimensionally 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 treatment other than their initial surgery; eight (36%) had received prior radiotherapy, and 12 (55%) chemotherapy. No patients had received prior immunotherapy. Treatment consisted of IL-2, 600,000 IU/kg administered by 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(10), 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.(ABSTRACT TRUNCATED AT 250 WORDS)
Hawkins
M J
MJ
Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland 20892.
Atkins
M B
MB
Dutcher
J P
JP
Fisher
R I
RI
Weiss
G R
GR
Margolin
K A
KA
Rayner
A A
AA
Sznol
M
M
Parkinson
D R
DR
Paietta
E
E
D000328:Adult; D002277:Carcinoma / Q000628:therapy*; D015179:Colorectal Neoplasms / Q000628:therapy*; D005260:Female; D006801:Humans; D007167:Immunotherapy; D007262:Infusions, Intravenous; D007376:Interleukin-2 / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D015979:Killer Cells, Lymphokine-Activated / Q000637:transplantation*; D008297:Male; D008875:Middle Aged
D007376:Interleukin-2