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Status unknownNCT00632333Updated Jul 21, 2011

Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer

A Phase 1 interventional study of URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil in Esophageal Cancer, sponsored by Teikyo University. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-07-21.

Sponsored by Teikyo University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
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Study summary

The purpose of this study is to evaluate the safety and immune response of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Read the detailed description

Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain containing protein over expressed in cancer (KOC1) were identified as new targets of tumor associated antigens using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be one of promising approaches for treating cancer. Vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T lymphocytes (CTL) restricted to HLA-A *2402 in vivo. On the other hand, chemotherapy (CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2) emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

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Conditions studied

  • Esophageal Cancer

Keywords

  • Epitope peptide
  • Vaccination
  • Chemoradiation
  • Esophageal cancer
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 9 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Teikyo University is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients must have unresectable, locally advanced, recurrent or metastatic disease of esophageal cancer.
  2. measurable disease by CT scan
  3. ECOG performance status of 0 to 2
  4. Expected survival of at lease 3months
  5. Patients must be HLA-A2402

  6. Laboratory values as follow:

    • WBC > 2000/mm3,
    • Platelet count > 75000/mm3,
    • Total bilirubin \< 1.5 x the institutional normal upper limits,
    • Creatinine \< 1.5 x the institutional normal upper limits,
    • AST. ALT. ALP \< 2.5 x the institutional normal upper limits
  7. Able and willing to give valid written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Active or uncontrolled infection
  4. Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks
  5. Concurrent treatment with steroid or immunosuppressing agent
  6. Patient with peptic ulcer disease
  7. Active or uncontrolled other malignancy
  8. Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
  9. Disease to the central nervous system
  10. Decision of unsuitableness by principal investigator or physician-in-charge
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    1

    Biological: URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil

Interventions

  • BiologicalURLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil

    Escalating dose of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 will be administered by subcutaneous injection on days 15, 22, 28 and 35 of treatment cycle. Doses of each peptide are planning 0.5mg, 1mg and 3mg/body. Chemotherapy plus radiation therapy will be done as follows: fluorouracil (400mg/m2) on day1-5 and 8-12, cisplatin (40mg/m2) on days 1 and 8, radiation (2Gy) on days 1-5, 8-12 and 15-19. Two cycles of combination of chemoradiation therapy and epitope peptide vaccine therapy will be done.

    Also known as: CDDP, 5-FU

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What researchers measure

Primary outcomes

  1. Safety(toxicities as assessed by NCI CTCAE version3)

    Time frame: 3 months

Secondary outcomes

  1. Peptide specific CTL induction

    Time frame: 3 months

  2. DTH to peptide

    Time frame: 3 months

  3. Changes in levels of regulatory T cells

    Time frame: 3 months

  4. Objective response rate as assessed by RECIST criteria

    Time frame: 1 year

  5. Time to progression

    Time frame: 1 year

  6. survival

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Teikyo University
    2-11-1 Kaga Itabashi-ku, Tokyo 173-0003, Japan
    Recruiting
08

References and documents

Publications

  • Yildirim Z, Kotuk M, Iraz M, Kuku I, Ulu R, Armutcu F, Ozen S. Attenuation of bleomycin-induced lung fibrosis by oral sulfhydryl containing antioxidants in rats: erdosteine and N-acetylcysteine. Pulm Pharmacol Ther. 2005;18(5):367-73. doi: 10.1016/j.pupt.2005.02.001. Epub 2005 Mar 23. PubMed 15939316 ↗
  • Li Y, Wang MN, Li H, King KD, Bassi R, Sun H, Santiago A, Hooper AT, Bohlen P, Hicklin DJ. Active immunization against the vascular endothelial growth factor receptor flk1 inhibits tumor angiogenesis and metastasis. J Exp Med. 2002 Jun 17;195(12):1575-84. doi: 10.1084/jem.20020072. Erratum In: J Exp Med 2002 Aug 19;196(4):557. PubMed 12070285 ↗
  • Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4. PubMed 12415261 ↗
  • Date Y, Kimura A, Kato H, Sasazuki T. DNA typing of the HLA-A gene: population study and identification of four new alleles in Japanese. Tissue Antigens. 1996 Feb;47(2):93-101. doi: 10.1111/j.1399-0039.1996.tb02520.x. PubMed 8851721 ↗
  • Correale P, Cusi MG, Del Vecchio MT, Aquino A, Prete SP, Tsang KY, Micheli L, Nencini C, La Placa M, Montagnani F, Terrosi C, Caraglia M, Formica V, Giorgi G, Bonmassar E, Francini G. Dendritic cell-mediated cross-presentation of antigens derived from colon carcinoma cells exposed to a highly cytotoxic multidrug regimen with gemcitabine, oxaliplatin, 5-fluorouracil, and leucovorin, elicits a powerful human antigen-specific CTL response with antitumor activity in vitro. J Immunol. 2005 Jul 15;175(2):820-8. doi: 10.4049/jimmunol.175.2.820. Erratum In: J Immunol. 2005 Nov 1;175(9):6235. Prete, Salvatore [corrected to Prete, Salvatore Pasquale]. PubMed 16002679 ↗
  • Nakopoulou L, Stefanaki K, Panayotopoulou E, Giannopoulou I, Athanassiadou P, Gakiopoulou-Givalou H, Louvrou A. Expression of the vascular endothelial growth factor receptor-2/Flk-1 in breast carcinomas: correlation with proliferation. Hum Pathol. 2002 Sep;33(9):863-70. doi: 10.1053/hupa.2002.126879. PubMed 12378509 ↗
  • Suda T, Tsunoda T, Uchida N, Watanabe T, Hasegawa S, Satoh S, Ohgi S, Furukawa Y, Nakamura Y, Tahara H. Identification of secernin 1 as a novel immunotherapy target for gastric cancer using the expression profiles of cDNA microarray. Cancer Sci. 2006 May;97(5):411-9. doi: 10.1111/j.1349-7006.2006.00194.x. PubMed 16630140 ↗
  • Watanabe T, Suda T, Tsunoda T, Uchida N, Ura K, Kato T, Hasegawa S, Satoh S, Ohgi S, Tahara H, Furukawa Y, Nakamura Y. Identification of immunoglobulin superfamily 11 (IGSF11) as a novel target for cancer immunotherapy of gastrointestinal and hepatocellular carcinomas. Cancer Sci. 2005 Aug;96(8):498-506. doi: 10.1111/j.1349-7006.2005.00073.x. PubMed 16108831 ↗
  • Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321. PubMed 9500606 ↗
  • Ishida K, Ando N, Yamamoto S, Ide H, Shinoda M. Phase II study of cisplatin and 5-fluorouracil with concurrent radiotherapy in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG)/Japan Clinical Oncology Group trial (JCOG9516). Jpn J Clin Oncol. 2004 Oct;34(10):615-9. doi: 10.1093/jjco/hyh107. Erratum In: Jpn J Clin Oncol. 2005 Feb;35(2):108. PubMed 15591460 ↗
  • Waters JS, Tait D, Cunningham D, Padhani AR, Hill ME, Falk S, Lofts F, Norman A, Oates J, Hill A. A multicentre phase II trial of primary chemotherapy with cisplatin and protracted venous infusion 5-fluorouracil followed by chemoradiation in patients with carcinoma of the oesophagus. Ann Oncol. 2002 Nov;13(11):1763-70. doi: 10.1093/annonc/mdf301. PubMed 12419749 ↗
  • Marchand M, van Baren N, Weynants P, Brichard V, Dreno B, Tessier MH, Rankin E, Parmiani G, Arienti F, Humblet Y, Bourlond A, Vanwijck R, Lienard D, Beauduin M, Dietrich PY, Russo V, Kerger J, Masucci G, Jager E, De Greve J, Atzpodien J, Brasseur F, Coulie PG, van der Bruggen P, Boon T. Tumor regressions observed in patients with metastatic melanoma treated with an antigenic peptide encoded by gene MAGE-3 and presented by HLA-A1. Int J Cancer. 1999 Jan 18;80(2):219-30. doi: 10.1002/(sici)1097-0215(19990118)80:23.0.co;2-s. PubMed 9935203 ↗
  • Iinuma H, Fukushima R, Inaba T, Tamura J, Inoue T, Ogawa E, Horikawa M, Ikeda Y, Matsutani N, Takeda K, Yoshida K, Tsunoda T, Ikeda T, Nakamura Y, Okinaga K. Phase I clinical study of multiple epitope peptide vaccine combined with chemoradiation therapy in esophageal cancer patients. J Transl Med. 2014 Apr 3;12:84. doi: 10.1186/1479-5876-12-84. PubMed 24708624 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00632333
Lead sponsor
Teikyo University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
First posted
Mar 10, 2008
Start date
Feb 2008
Primary completion
Dec 2011 (estimated)
Completion
Mar 2012 (estimated)
Last update
Jul 21, 2011

Study contacts

Hisae Iinuma, PhD
Contact
iinuma@med.teikyo-u.ac.jp
+81-33-964-1211
Kota Okinaga, MD, PhD
study chair · Teikyo University , Department Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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