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Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

IMF-001

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aichi Cancer Center Hospital
Mie University Hospital
Kitano Hospital
Osaka University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMF-001

Arm Description

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).

Outcomes

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.

Secondary Outcome Measures

To evaluate clinical activity (tumor response and time to progression).

Full Information

NCT ID

NCT01003808

First Posted

October 16, 2009

Last Updated

April 16, 2013

Sponsor

ImmunoFrontier, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01003808

Brief Title

Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

Official Title

IMF-001 Phase 1 Study With Refractory Esophageal Tumor

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ImmunoFrontier, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMF-001

Arm Type

Experimental

Arm Description

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).

Intervention Type

Biological

Intervention Name(s)

IMF-001

Other Intervention Name(s)

CHP-NY-ESO-1

Intervention Description

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).

Primary Outcome Measure Information:

Title

Time Frame

First 12 weeks (during the first 6 injections)

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daiju Ichimaru, BSc

Organizational Affiliation

ImmunoFrontier, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Aichi Cancer Center Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Mie University Hospital

City

TSU

State/Province

Mie

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

Kitano Hospital

City

Kitano Hospital

State/Province

Osaka

ZIP/Postal Code

530-8480

Country

Japan

Facility Name

Osaka University Hospital

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

19761832

Citation

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.

Results Reference

background

PubMed Identifier

18772606

Citation

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.

Results Reference

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PubMed Identifier

18311489

Citation

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.

Results Reference

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PubMed Identifier

17441676

Citation

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.

Results Reference

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PubMed Identifier

17278093

Citation

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. doi: 10.1002/ijc.22583.

Results Reference

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PubMed Identifier

16551878

Citation

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. doi: 10.1158/1078-0432.CCR-05-1900.

Results Reference

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PubMed Identifier

24093426

Citation

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.

Results Reference

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Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

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