HER2-Peptide Vaccination of Patients With Solid Tumors (HER2)
Primary Purpose
Gastric Cancer, Breast Cancer
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Cyclophosphamide
Sargramostim
HER2-Peptid-Vakzine
Imiquimod
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HER2-Peptid-Vakzine, Cyclophosphamide
Arm Description
Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02276300
First Posted
September 25, 2014
Last Updated
November 18, 2019
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT02276300
Brief Title
HER2-Peptide Vaccination of Patients With Solid Tumors
Acronym
HER2
Official Title
A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
July 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Breast 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
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HER2-Peptid-Vakzine, Cyclophosphamide
Arm Type
Experimental
Arm Description
Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan
Intervention Description
Treatment of mild Endoxan application three days before Her2 vaccination
Intervention Type
Drug
Intervention Name(s)
Sargramostim
Other Intervention Name(s)
Leukine
Intervention Description
Sargramostim is part of Her2 vaccination
Intervention Type
Drug
Intervention Name(s)
HER2-Peptid-Vakzine
Intervention Description
Her2 vaccination is supplemented by Sargramostim and Aldara Creme application
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Aldara 5% Crème
Intervention Description
Imiquimod is part of Her2 vaccination
Primary Outcome Measure Information:
Title
Safety and tolerability of HER2-derived peptide vaccination measured by clinical and chemical parameters.
Description
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.
Time Frame
Safety measurement will be assessed up to 113 days relating to start of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Krackhardt, Prof.Dr.med.
Organizational Affiliation
III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
City
Munic
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
HER2-Peptide Vaccination of Patients With Solid Tumors
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