Vaccination of Renal Cell Cancer Patients With Modified Vaccinia Ankara Delivering the Tumor Antigen 5T4 (TroVax) Alone or Administered in Combination With Interferon-α (IFN-α) A Phase 2 Trial
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作者:
Amato, Robert J.
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Univ Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USAUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Amato, Robert J.
[1
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Shingler, William
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Oxford BioMed UK Ltd, Medawar Ctr, Oxford, EnglandUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Shingler, William
[3
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Goonewardena, Madusha
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Oxford BioMed UK Ltd, Medawar Ctr, Oxford, EnglandUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Goonewardena, Madusha
[3
]
de Belin, Jackie
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Oxford BioMed UK Ltd, Medawar Ctr, Oxford, EnglandUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
de Belin, Jackie
[3
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Naylor, Stuart
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Oxford BioMed UK Ltd, Medawar Ctr, Oxford, EnglandUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Naylor, Stuart
[3
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Jac, Jaroslaw
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Methodist Hosp, Res Inst, Texas Med Ctr, Houston, TX 77030 USAUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Jac, Jaroslaw
[2
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Willis, James
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Methodist Hosp, Res Inst, Texas Med Ctr, Houston, TX 77030 USAUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Willis, James
[2
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Saxena, Somyata
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Methodist Hosp, Res Inst, Texas Med Ctr, Houston, TX 77030 USAUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Saxena, Somyata
[2
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Hernandez-McClain, Joan
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Univ Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USAUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Hernandez-McClain, Joan
[1
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Harrop, Richard
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Oxford BioMed UK Ltd, Medawar Ctr, Oxford, EnglandUniv Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
Harrop, Richard
[3
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机构:
[1] Univ Texas Hlth Sci Ctr, Mem Hermann Canc Ctr, Houston, TX 77030 USA
[2] Methodist Hosp, Res Inst, Texas Med Ctr, Houston, TX 77030 USA
[3] Oxford BioMed UK Ltd, Medawar Ctr, Oxford, England
Attenuated vaccinia virus, modified vaccinia Ankara (MVA) has been engineered to deliver the tumor antigen 5T4 (TroVax). MVA-5T4 has been evaluated in an open-label phase 2 trial in metastatic renal cell cancer patients in which the vaccine was administered alone or in combination with interferon-alpha-2b (IFN-alpha). The safety, immunologic and clinical efficacy of MVA-5T4 with or without IFN-alpha was determined. Twenty-eight patients with metastatic renal cell cancer were treated with MVA-5T4 alone (13) or plus IFN-alpha (15). The 5T4-specific cellular and humoral responses were monitored throughout the Study. Clinical responses were assessed by measuring changes in tumor burden by computed tomography or magnetic resonance imaging scan. MVA-5T4 was well tolerated with 110 Serious adverse event attributed to vaccination. Of 23 intent-to-treat patients tested for immune responses postvaccination, 22 (96%) mounted 5T4-specific antibody and/or cellular responses. One patient treated with MVA-5T4 plus IFN-alpha showed a partial response for > 7 months, whereas an additional 14 patients (7 receiving MVA-5T4 Plus IFN and 7 receiving MVA-5T4 alone) showed periods of disease stabilization ranging from 1.73 to 9.60 months. Median progression free survival and overall survival for all intent-to-treat patients was 3.8 months (range: 1 to 11.47mo) and 12.1 months (range: 1 to 27 mo), respectively. MVA-5T4 administered alone or in combination with IFN-alpha was well tolerated in all patients. Despite the high frequency of 5T4-speciric immune responses, it is not possible to conclude that patients are receiving clinical benefit. The results are encouraging and warrant further investigation.
机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Griffiths, RW
Gilham, DE
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Gilham, DE
Dangoor, A
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Dangoor, A
Ramani, V
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Ramani, V
Clarke, NW
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Clarke, NW
Stern, PL
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Stern, PL
Hawkins, RE
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Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, EnglandChristie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Griffiths, RW
Gilham, DE
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Gilham, DE
Dangoor, A
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Dangoor, A
Ramani, V
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Ramani, V
Clarke, NW
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Clarke, NW
Stern, PL
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机构:Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England
Stern, PL
Hawkins, RE
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Christie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, EnglandChristie Res Ctr, Paterson Inst Canc Res, Dept Med Oncol, Manchester M20 4BX, Lancs, England