Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT01003808

Recruitment Status : Completed

First Posted : October 29, 2009

Last Update Posted : April 17, 2013

Sponsor:

Information provided by (Responsible Party):

ImmunoFrontier, Inc.

Study Description

Brief Summary:

The purpose of this study is to determine the biological recommended dose of IMF-001.

Condition or disease	Intervention/treatment	Phase
Esophageal Cancer	Biological: IMF-001	Phase 1

Detailed Description:

The prognosis of esophageal cancer is improved with the improvement of surgery, chemotherapy and radiation therapy. However, there are no standard therapies established for recurrent esophageal cancer. NY-ESO-1 antigen is expressed in 33% of patients. NY-ESO-1 protein is applicable without limitation by HLA types, and injected as a complex with cholesteryl pullulan (CHP), forming nano-particles (IMF-001), it can activate both CD4+ and CD8+ T cells. In this phase 1 study, the safety and the biological recommended dose will be determined.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	IMF-001 Phase 1 Study With Refractory Esophageal Tumor
Study Start Date :	November 2009
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Esophageal Cancer

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: IMF-001 100 or 200 mcg, subcutaneously every 2 weeks. Number of Injections: 6 times. (The treatment may be continued if it is beneficial to the subject).	Biological: IMF-001 100 or 200 mcg, subcutaneously every 2 weeks. Number of Injections: 6 times. (The treatment may be continued if it is beneficial to the subject). Other Name: CHP-NY-ESO-1

Outcome Measures

Primary Outcome Measures :

To evaluate the maximum tolerated dose, dose-limiting toxicities, type/frequency/degree of adverse events and NY-ESO-1 antigen-specific immune response of IMF-001 alone in patients with esophageal cancer. [ Time Frame: First 12 weeks (during the first 6 injections) ]

Secondary Outcome Measures :

To evaluate clinical activity (tumor response and time to progression). [ Time Frame: Up to 2 years, or until progression of PS or no positive immune response from IMF-001. ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Radically unresectable stage III/IV esophageal tumors that have failed the standard treatment (including chemotherapy and radiotherapy), recurrent metastasis after radical surgery and not responding to the standard treatments, or recurrent metastasis after radiotherapy before/after radical surgery.
Primary esophageal tumors confirmed by pathological diagnosis
Tumor cells expressing NY-ESO-1 antigen (by tissue-immunostaining method or quantitative RT-PCR method)
Performance status (PS) of 0, 1 or 2 (ECOG Scale)
Life expectancy >/= 4 months
No serious disorders with major organs (bone marrow, heart, lung, liver and kidney) and meets the following criteria:
- WBC count >/= 2.0 x 10 9/L
- Hemoglobin >/=8.0g/dL
- Platelet count >/=75 x 10 9/L
- Serum total bilirubin: </=1.5 x ULN (3 x ULN if with liver mets)
- AST and ALT: </=2.5 x ULN (5x ULN if with liver mets)
- Serum creatinine: </=1.5x ULN
Agree to use birth control including condoms from the time of obtaining the consent to 6 months after the final administration of the study drug [except females after menopause (1 year or more after the last menstruation and females/males after an operation for sterilization)]
Given written informed consent

Exclusion Criteria:

HIV antibody positive
Double cancer
History of autoimmune disease
History of severe anaphylaxis
Active metastatic disease in the central nervous system (CNS) Within 4 weeks after treatment with an anti-tumor agent, systemically administered adrenocorticosteroids, immune suppressants or immune enhancers
Pregnant or lactating
Any other inadequacy for this study

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003808

Locations

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Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
Mie University Hospital
TSU, Mie, Japan, 514-8507
Kitano Hospital
Kitano Hospital, Osaka, Japan, 530-8480
Osaka University Hospital
Suita, Osaka, Japan, 565-0871

Sponsors and Collaborators

ImmunoFrontier, Inc.

Investigators

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Study Director:	Daiju Ichimaru, BSc	ImmunoFrontier, Inc.

More Information

Publications:

Aoki M, Ueda S, Nishikawa H, Kitano S, Hirayama M, Ikeda H, Toyoda H, Tanaka K, Kanai M, Takabayashi A, Imai H, Shiraishi T, Sato E, Wada H, Nakayama E, Takei Y, Katayama N, Shiku H, Kageyama S. Antibody responses against NY-ESO-1 and HER2 antigens in patients vaccinated with combinations of cholesteryl pullulan (CHP)-NY-ESO-1 and CHP-HER2 with OK-432. Vaccine. 2009 Nov 16;27(49):6854-61. doi: 10.1016/j.vaccine.2009.09.018. Epub 2009 Sep 15.

Harada N, Hoshiai K, Takahashi Y, Sakaguchi Y, Kuno T, Hishida T, Shiku H. Preclinical safety pharmacology study of a novel protein-based cancer vaccine CHP-NY-ESO-1. Kobe J Med Sci. 2008 May 23;54(1):E23-34.

Tsuji K, Hamada T, Uenaka A, Wada H, Sato E, Isobe M, Asagoe K, Yamasaki O, Shiku H, Ritter G, Murphy R, Hoffman EW, Old LJ, Nakayama E, Iwatsuki K. Induction of immune response against NY-ESO-1 by CHP-NY-ESO-1 vaccination and immune regulation in a melanoma patient. Cancer Immunol Immunother. 2008 Oct;57(10):1429-37. doi: 10.1007/s00262-008-0478-5. Epub 2008 Mar 1.

Uenaka A, Wada H, Isobe M, Saika T, Tsuji K, Sato E, Sato S, Noguchi Y, Kawabata R, Yasuda T, Doki Y, Kumon H, Iwatsuki K, Shiku H, Monden M, Jungbluth AA, Ritter G, Murphy R, Hoffman E, Old LJ, Nakayama E. T cell immunomonitoring and tumor responses in patients immunized with a complex of cholesterol-bearing hydrophobized pullulan (CHP) and NY-ESO-1 protein. Cancer Immun. 2007 Apr 19;7:9.

Kawabata R, Wada H, Isobe M, Saika T, Sato S, Uenaka A, Miyata H, Yasuda T, Doki Y, Noguchi Y, Kumon H, Tsuji K, Iwatsuki K, Shiku H, Ritter G, Murphy R, Hoffman E, Old LJ, Monden M, Nakayama E. Antibody response against NY-ESO-1 in CHP-NY-ESO-1 vaccinated patients. Int J Cancer. 2007 May 15;120(10):2178-84.

Hasegawa K, Noguchi Y, Koizumi F, Uenaka A, Tanaka M, Shimono M, Nakamura H, Shiku H, Gnjatic S, Murphy R, Hiramatsu Y, Old LJ, Nakayama E. In vitro stimulation of CD8 and CD4 T cells by dendritic cells loaded with a complex of cholesterol-bearing hydrophobized pullulan and NY-ESO-1 protein: Identification of a new HLA-DR15-binding CD4 T-cell epitope. Clin Cancer Res. 2006 Mar 15;12(6):1921-7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kageyama S, Wada H, Muro K, Niwa Y, Ueda S, Miyata H, Takiguchi S, Sugino SH, Miyahara Y, Ikeda H, Imai N, Sato E, Yamada T, Osako M, Ohnishi M, Harada N, Hishida T, Doki Y, Shiku H. Dose-dependent effects of NY-ESO-1 protein vaccine complexed with cholesteryl pullulan (CHP-NY-ESO-1) on immune responses and survival benefits of esophageal cancer patients. J Transl Med. 2013 Oct 5;11:246. doi: 10.1186/1479-5876-11-246.

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Responsible Party:	ImmunoFrontier, Inc.
ClinicalTrials.gov Identifier:	NCT01003808
Other Study ID Numbers:	IMF001J
First Posted:	October 29, 2009 Key Record Dates
Last Update Posted:	April 17, 2013
Last Verified:	April 2013

Additional relevant MeSH terms:

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Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

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