Gastric CancerPhase 1HER2NCT02276300
HER2-Peptide Vaccination of Patients With Solid Tumors
A Phase 1 study testing Cyclophosphamide, Sargramostim and HER2-Peptid-Vakzine in people with Gastric Cancer and Breast Cancer, run by Technical University of Munich at 1 site in Germany.
Trial summary
Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast or gastric cancer with moderate HER2/neu expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Breast Cancer
- What is being tested?
- Cyclophosphamide, Sargramostim and HER2-Peptid-Vakzine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to 13 Jul 2018
- 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
- Patients with stage IV metastasized breast or gastric cancer with documented stable disease or objective response after at least first line chemo/ radiotherapy for advanced disease
- HER2 IHC score 2+ on tumor cells, negative FISH result
- HLA-A2 expression
- Female or male patients aged >= 18 years
- Measurable disease according to RECIST criteria
- ECOG 0-1
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- Neutrophile count > 1,5x10^9/l
- WBC > 2,5x10^9/l
- Lymphocyte count > 1x10^9/l
- Hemoglobin > 10g/dl
- Platelets > 100x10^9/l
- Normal renal function (creatinine < 150% ULN)
- Normal liver function (Bilirubin < 150% ULN; ALAT/SGPT and ASAT/SGOT < 300% ULN, except proven metastases)
- Expected survival of at least 6 months
- Concomitant anti-hormonal treatment is allowed
- Female patients within child bearing age must have a negative pregnancy test performed not earlier than 21 days before administration of investigational product. Male and female patients with reproductive potential must agree to employ an effective method of birth control throughout the study and for 6 months discontinuation of investigational product. Postmenopausal women must be amenorrheal for at least 12 months to be considered of non-childbearing potential.
- Men and women of childbearing potential must agree to use a highly effective method of birth control which results in a low failure rate (less than 1% per year) when used consistently and correctly.
- Written informed consent that the patient or a legally authorized representative has been informed about all aspects of the study prior to enrollment and is willing to participate and to be included in the study
- Ability to understand and comply with study and follow-up procedures
Who cannot join
- Treatment with any other investigational drug within 4 weeks prior to the start of the study medication
- Known hypersensitivity to any components of the study product
- Any severe concomitant disease
- Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, unstable angina, heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease, obstructive or restrictive lung disease) metabolic dysfunction) and physical examination finding likely (in the investigator's opinion) to affect the evaluation of the study or to put patient at risk associated to treatment with the study medication.
- Any heart disease
- Any serious infection or sepsis
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- Any autoimmune disorder
- Infection with HIV, chronic infection with Hepatitis B or C
- Any immunodeficiency syndrome
- Surgery within 4 weeks before study entry
- Prior splenectomy
- Brain metastasis or leptomeningeal involvement
- Systemic application of immunosuppressive drugs including systemic corticosteroids within three weeks before study entry
- Patients eligible or treated with any aproved HER2-targeted therapy as Trastuzumab, Pertzuzumab, T-DM1 or Lapatinib
- Radio-, chemo- or immunotherapy other than study medication in parallel or within 4 weeks prior study start
- Active drug abuse or chronic alcoholism
- Pregnancy or breast feeding
- Female and male patients of reproductive potential unwilling or unable to practice a highly effective method of birth control
- History of non-compliance with medical regimens
- Patients unwilling or unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
Germany1 site
III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
Munich, Bavaria, 81675
About this study
Official title: A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu
Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast or gastric cancer with moderate HER2/neu expression.
Read the detailed description
This is an interventional phase I clinical study to investigate the safety, tolerability and efficacy of HER2-derived peptide vaccination. HLA-A2+ patients with stage IV metastasized breast or gastric cancer with HER2 expression (IHC Score 2+) without gene amplification proved by FISH analysis, with documented stable disease or objective response after at least first line systemic chemotherapy/radiotherapy for advanced disease who have not been treated for the underlying malignant disease for 4 weeks with chemo-, radio- or immunotherapy will be included into the study. The aim of the study is to show safety and tolerability of this immunotherapeutic approach and to investigate efficacy of the immunotherapy.
- Conditions
- Gastric Cancer, Breast Cancer
- Being tested
- Cyclophosphamide, Sargramostim, HER2-Peptid-Vakzine, Imiquimod
- Medical subject headings
- Stomach Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Endoxan
Treatment of mild Endoxan application three days before Her2 vaccination
SargramostimDrug
Also called Leukine
Sargramostim is part of Her2 vaccination
HER2-Peptid-VakzineDrug
Her2 vaccination is supplemented by Sargramostim and Aldara Creme application
ImiquimodDrug
Also called Aldara 5% Crème
Imiquimod is part of Her2 vaccination
| Study group | Role | What they receive |
|---|---|---|
| HER2-Peptid-Vakzine, Cyclophosphamide | Experimental | Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide Receives: Drug: Cyclophosphamide; Drug: Sargramostim; Drug: HER2-Peptid-Vakzine; Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of HER2-derived peptide vaccination measured by clinical and chemical parameters.
To examine the safety and tolerability of HER2-derived peptide vaccination in patients with stage IV metastasized breast or gastric cancer with documented stable disease or objective response after at least first line systemic chemotherapy/radiotherapy for advanced disease.
Measured: Safety measurement will be assessed up to 113 days relating to start of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startDec 2014
- Primary completion18 Jul 2017
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Krackhardt, Prof.Dr.med., Principal investigator, III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276300
- Sponsor's protocol ID
- ATZ-1068-KRA-20I
- Acronym
- HER2
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2014
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu
- ClinicalTrials.gov ID
- NCT02276300
- Acronym / sponsor ID
- HER2 / ATZ-1068-KRA-20I
- Conditions
- Gastric Cancer, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 28 Oct 2014 (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.
Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast or gastric cancer with moderate HER2/neu expression.
Detailed description
This is an interventional phase I clinical study to investigate the safety, tolerability and efficacy of HER2-derived peptide vaccination. HLA-A2+ patients with stage IV metastasized breast or gastric cancer with HER2 expression (IHC Score 2+) without gene amplification proved by FISH analysis, with documented stable disease or objective response after at least first line systemic chemotherapy/radiotherapy for advanced disease who have not been treated for the underlying malignant disease for 4 weeks with chemo-, radio- or immunotherapy will be included into the study. The aim of the study is to show safety and tolerability of this immunotherapeutic approach and to investigate efficacy of the immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-Peptid-Vakzine, Cyclophosphamide | Experimental | Drug: Cyclophosphamide, Drug: Sargramostim, Drug: HER2-Peptid-Vakzine, Drug: ImiquimodHer2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with stage IV metastasized breast or gastric cancer with documented stable disease or objective response after at least first line chemo/ radiotherapy for advanced disease
- HER2 IHC score 2+ on tumor cells, negative FISH result
- HLA-A2 expression
- Female or male patients aged >= 18 years
- Measurable disease according to RECIST criteria
Key exclusion criteria (20 listed)
- Treatment with any other investigational drug within 4 weeks prior to the start of the study medication
- Known hypersensitivity to any components of the study product
- Any severe concomitant disease
- Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, unstable angina, heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease, obstructive or restrictive lung disease) metabolic dysfunction) and physical examination finding likely (in the investigator's opinion) to affect the evaluation of the study or to put patient at risk associated to treatment with the study medication.
- Any heart disease
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 |
|---|---|---|
| CyclophosphamideAlso: EndoxanTreatment of mild Endoxan application three days before Her2 vaccination | Drug | HER2-Peptid-Vakzine, Cyclophosphamide |
| SargramostimAlso: LeukineSargramostim is part of Her2 vaccination | Drug | HER2-Peptid-Vakzine, Cyclophosphamide |
| HER2-Peptid-VakzineHer2 vaccination is supplemented by Sargramostim and Aldara Creme application | Drug | HER2-Peptid-Vakzine, Cyclophosphamide |
| ImiquimodAlso: Aldara 5% CrèmeImiquimod is part of Her2 vaccination | Drug | HER2-Peptid-Vakzine, Cyclophosphamide |
Primary outcome
Safety and tolerability of HER2-derived peptide vaccination measured by clinical and chemical parameters.
Time frame: Safety measurement will be assessed up to 113 days relating to start of study treatment
To examine the safety and tolerability of HER2-derived peptide vaccination in patients with stage IV metastasized breast or gastric cancer with documented stable disease or objective response after at least first line systemic chemotherapy/radiotherapy for advanced disease.
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 20 Nov 2019.
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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.
Angela Krackhardt, Prof.Dr.med. principal investigator
III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
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 Cyclophosphamide, Sargramostim and HER2-Peptid-Vakzine in people with Gastric Cancer and Breast Cancer, run by Technical University of Munich at 1 site in Germany.
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 19 inclusion and 20 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 20 Nov 2019. 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 Germany. 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?
Safety and tolerability of HER2-derived peptide vaccination measured by clinical and chemical parameters. (time frame: Safety measurement will be assessed up to 113 days relating to start of study treatment). 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 20 Nov 2019.