Esophageal CancerPhase 1NCT00291473
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
A Phase 1 study testing CHP-HER2, CHP-NY-ESO-1 in people with Esophageal Cancer and Lung Cancer, run by Ludwig Institute for Cancer Research at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Lung Cancer, Stomach Cancer
- What is being tested?
- CHP-HER2, CHP-NY-ESO-1
- How many people
- 9 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2005to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Lack of availability for immunological and clinical follow-up assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Cholesterol-Bearing Hydrophobized Pullulan HER2 Protein 146 (CHP-HER2) and NY-ESO-1 Protein (CHP-NY-ESO-1) in Combination With OK-432 in HER2- and/or NY-ESO-1-Expressing Cancers
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.
- Conditions
- Esophageal Cancer, Lung Cancer, Stomach Cancer, Breast Cancer, Ovarian Cancer
- Being tested
- CHP-HER2, CHP-NY-ESO-1
- Medical subject headings
- Esophageal Neoplasms, Lung Neoplasms, Stomach Neoplasms, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHP-HER2, CHP-NY-ESO-1Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Secondary outcomes (1)
immune responses including HER2 and NY-ESO-1 specific IgG and T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startJul 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- Mie University
- Investigators
- Hiroshi Shiku, M.D., Principal investigator, Mie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291473
- Sponsor's protocol ID
- LMT2004-011
- Status last verified
- Mar 2009
- First submitted
- 10 Feb 2006
- Last updated
- 3 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Cholesterol-Bearing Hydrophobized Pullulan HER2 Protein 146 (CHP-HER2) and NY-ESO-1 Protein (CHP-NY-ESO-1) in Combination With OK-432 in HER2- and/or NY-ESO-1-Expressing Cancers
- ClinicalTrials.gov ID
- NCT00291473
- Acronym / sponsor ID
- LMT2004-011
- Conditions
- Esophageal Cancer, Lung Cancer, Stomach Cancer, Breast Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Ludwig Institute for Cancer ResearchUniversity, hospital or other
- Collaborators
- Mie University
- Study start
- Jul 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Complete recovery from surgery (at least 4 weeks).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHP-HER2, CHP-NY-ESO-1 | Drug | – |
Primary outcome
adverse events
1 secondary outcome
immune responses including HER2 and NY-ESO-1 specific IgG and T cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Shiku, M.D. principal investigator
Mie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHP-HER2, CHP-NY-ESO-1 in people with Esophageal Cancer and Lung Cancer, run by Ludwig Institute for Cancer Research at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2009.