A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu
Overview
- Phase
- Phase 1
- Intervention
- Cyclophosphamide
- Conditions
- Gastric Cancer
- Sponsor
- Technical University of Munich
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of HER2-derived peptide vaccination measured by clinical and chemical parameters.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
- •Neutrophile count \> 1,5x10\^9/l
- •WBC \> 2,5x10\^9/l
- •Lymphocyte count \> 1x10\^9/l
- •Hemoglobin \> 10g/dl
- •Platelets \> 100x10\^9/l
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
Arms & Interventions
HER2-Peptid-Vakzine, Cyclophosphamide
Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide
Intervention: Cyclophosphamide
HER2-Peptid-Vakzine, Cyclophosphamide
Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide
Intervention: Sargramostim
HER2-Peptid-Vakzine, Cyclophosphamide
Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide
Intervention: HER2-Peptid-Vakzine
HER2-Peptid-Vakzine, Cyclophosphamide
Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide
Intervention: Imiquimod
Outcomes
Primary Outcomes
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.