NCT01003808

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2009

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

2.3 years

First QC Date

October 16, 2009

Last Update Submit

April 16, 2013

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    First 12 weeks (during the first 6 injections)

Secondary Outcomes (1)

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

    Up to 2 years, or until progression of PS or no positive immune response from IMF-001.

Study Arms (1)

IMF-001

EXPERIMENTAL

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

Interventions

IMF-001BIOLOGICAL

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).

Also known as: CHP-NY-ESO-1
IMF-001

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Kitano Hospital

Kitano Hospital, Osaka, 530-8480, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Related Publications (7)

  • 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.

    PMID: 19761832BACKGROUND

  • 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.

    PMID: 18772606BACKGROUND

  • 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.

    PMID: 18311489BACKGROUND

  • 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.

    PMID: 17441676BACKGROUND

  • 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.

    PMID: 17278093BACKGROUND

  • 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.

    PMID: 16551878BACKGROUND

  • 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.

    PMID: 24093426DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Daiju Ichimaru, BSc

    ImmunoFrontier, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 29, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

JP(4)