NCT00291473

Brief Summary

Mixed cancer vaccines, CHP-HER2 protein and CHP-NY-ESO-1 protein, are to be studied to evaluate the safety and immune responses in patients who are positive either or both antigens. Nine patients will be enrolled, who are refractory to standard therapies for cancer or at high risk to relapse. CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly basis, together with OK-432(Picibanil) as an immunoadjuvant. Six doses will be given. Toxicity profiles will be monitored, and antigen specific humoral anad T cell responses will be described.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

March 3, 2009

Status Verified

March 1, 2009

Enrollment Period

3.1 years

First QC Date

February 10, 2006

Last Update Submit

March 2, 2009

Conditions

Esophageal CancerLung CancerStomach CancerBreast CancerOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • adverse events

Secondary Outcomes (1)

  • immune responses including HER2 and NY-ESO-1 specific IgG and T cells

Interventions

CHP-HER2, CHP-NY-ESO-1DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological confirmation of cancer.
  • HER2 expression in tumor cells scored as 1+ or more which should be confirmed by IHC using at least two antibodies (archived issue; see Appendix 1 and Reference 1 for methodology).
  • or NY-ESO-1 expression by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis (Appendix 2), preferably, or immunohistochemistry
  • Patients must
  • are at high risk of recurrence, more than 25% of probability, after complete resection or even after post-operative adjuvant treatment, and effective adjuvant therapy is not available or refused; or
  • have metastatic disease, and treatment has failed, or in the situation where effective therapy is not available, or has been refused.
  • Complete recovery from surgery (at least 4 weeks).
  • Laboratory values within the following limits:
  • Hemoglobin 9.0 g/dL or more, or 10.0 g/dL or more if \<50 kg Neutrophil count \>1.5 x 109/L Lymphocyte count \>0.5 x 109/L Platelet count \>100 x 109/L Serum creatinine ≤ 1.8 mg/dL Serum bilirubin ≤ 2 mg/dL
  • Performance status \> 70 (Karnofsky Scale) and life expectancy \>3 months.
  • Age 18 years or more.

You may not qualify if:

  • Clinically significant heart disease (NYHA Class III or IV).
  • Cardiac dysfunction; less than 50% of ejection fraction by echocardiogram.
  • Immunodeficiency disease.
  • Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
  • Previous bone marrow or stem cell transplant.
  • Metastatic disease to the central nervous system, unless treated and stable.
  • known HIV antibody positivity.
  • Anaphylactic reaction to previous vaccination.
  • Hypersensitivity to penicillin
  • Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
  • Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
  • Pregnancy or nursing .
  • Refusal, by women of childbearing potential, to use medically acceptable means of contraception.
  • Mental impairment that may compromise the ability to give informed consent.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

MeSH Terms

Conditions

Esophageal NeoplasmsLung NeoplasmsStomach NeoplasmsBreast NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesStomach DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Hiroshi Shiku, M.D.

    Mie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 14, 2006

Study Start

July 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

March 3, 2009

Record last verified: 2009-03

Locations

JP(1)