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Cancer Therapy: Clinical

A Phase I Study of α-Galactosylceramide (KRN7000)–Pulsed Dendritic Cells in Patients with Advanced and Recurrent Non–Small Cell Lung Cancer

Aki Ishikawa, Shinichiro Motohashi, Eiichi Ishikawa, Hiroki Fuchida, Kazuko Higashino, Mizuto Otsuji, Toshihiko Iizasa, Toshinori Nakayama, Masaru Taniguchi and Takehiko Fujisawa
Aki Ishikawa
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Shinichiro Motohashi
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Eiichi Ishikawa
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Hiroki Fuchida
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Kazuko Higashino
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Mizuto Otsuji
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Toshihiko Iizasa
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Toshinori Nakayama
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Masaru Taniguchi
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Takehiko Fujisawa
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DOI: 10.1158/1078-0432.CCR-04-1453 Published March 2005
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    Fig. 1

    Experimental design of αGalCer-pulsed APC administration. *, injection of αGalCer nonpulsed APCs. The patients received αGalCer-pulsed APC containing DCs (DC#1, DC#2, DC#3, and DC#4). The timings of apheresis and DC administration are shown.

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    Fig. 2

    Flow cytometric analysis of αGalCer-pulsed APC (GM/IL-2 DC). A, forward scatter/side scatter (FS/SS) profiles with gates of the administered cells; dashed line, gate for B; solid line, gate for C. B, expression levels of HLA-DR, CD11c, CD86, CD83, CD80, and CD14 were assessed by flow cytometric analysis at the time of administration. Solid lines, background staining with an isotype control. Bold lines, staining profiles of the indicated molecules. Data are for three patients in the level 3 group. C, summary of the contents of cells administered. Each patient received αGalCer-pulsed APCs (GM/IL-2 DC) four times. The mean percentages of the indicated fractions in the administered cells are shown with SDs.

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    Fig. 3

    Points, numbers of peripheral blood Vα24 NKT cells during the course of treatment in three patients in the level 3 group. The numbers and percentages of peripheral blood Vα24 NKT cells (Vα24+Vβ11+cells) during the course of treatment in three patients in the level 3 group were assessed by flow cytometric analysis. The frequency of Vα24 NKT cells in the total PBMCs of each patients is as follows; case 009, 0.01%; case 010, 0.03%; and case 011, 0.012%.

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    Fig. 4

    Increased expression of IFN-γ in Vα24 NKT cells after administration of αGalCer-pulsed DCs. The ability to produce IFN-γ in peripheral blood Vα24 NKT cells during the course of treatment in case 010 was determined by quantitative reverse transcription-PCR. Whole PBMC was activated with immobilized anti-CD3ε overnight. Vα24+Vβ11+ NKT cells were sorted and quantitative reverse transcription-PCR for IFN-γ and Cα was done. Columns, relative IFN-γ mRNA (copy numbers of IFN-γ mRNA normalized to the copy numbers of TCR Cα mRNA in 100 Vα24+Vβ11+ NKT cells) for triplicate cultures; bars, SD. *, not detected.

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    Characteristics of enrolled patients

    Total number entered11
        Completions/dropouts9/2
    Median age (range)69.0 (63-78)
    Gender, male/female8/3
    PS, 0/1/29/2/0
    Histology, Ad*/Sq**/large***9/1/1
    Clinical staging, IV/recurrence2/9
    Prior treatment: surgey/radiation/chemotherapy/none2/4/6/1
    • NOTE. Values represent numbers of patients.

    • Abbreviations: PS, performance status; Ad; adenocarcinoma; Sq, squamous cell carcinoma.

  • Table 2

    Patient profiles and adverse events observed

    Level events (grade)CaseAge/genderDiagnosisCancer lesionPretreatmentAdverse
    100165/FRecLungOPHot flash(I), headache(I), hyperkalemia(II), cretinine(I)
    00263/MRecLungNoneHyperkalemia(II)
    00368/MRecLungCTNone
    200665/MRecLung, brain, boneCT, RTHyperbilirubinemia
    00778/MRecLungRTHyperkalemia(I)
    00867/MRecLungRTNone
    300961/MPrimaryLung, bone, adrenal glandRTNone
    01066/FRecLung, pleuraOP, CTHeadache(I), cytitis(II), general fatigue(II)
    01174/FPrimaryLung, pleura, boneCTNone
    • Abbreviations: M, male; F, female; rec, recurrence; primary, primary lung cancer; ST, surgical treatment; CT, chemotherapy; RT, radiation therapy.

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Clinical Cancer Research: 11 (5)
March 2005
Volume 11, Issue 5
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A Phase I Study of α-Galactosylceramide (KRN7000)–Pulsed Dendritic Cells in Patients with Advanced and Recurrent Non–Small Cell Lung Cancer
Aki Ishikawa, Shinichiro Motohashi, Eiichi Ishikawa, Hiroki Fuchida, Kazuko Higashino, Mizuto Otsuji, Toshihiko Iizasa, Toshinori Nakayama, Masaru Taniguchi and Takehiko Fujisawa
Clin Cancer Res March 1 2005 (11) (5) 1910-1917; DOI: 10.1158/1078-0432.CCR-04-1453

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A Phase I Study of α-Galactosylceramide (KRN7000)–Pulsed Dendritic Cells in Patients with Advanced and Recurrent Non–Small Cell Lung Cancer
Aki Ishikawa, Shinichiro Motohashi, Eiichi Ishikawa, Hiroki Fuchida, Kazuko Higashino, Mizuto Otsuji, Toshihiko Iizasa, Toshinori Nakayama, Masaru Taniguchi and Takehiko Fujisawa
Clin Cancer Res March 1 2005 (11) (5) 1910-1917; DOI: 10.1158/1078-0432.CCR-04-1453
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