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HER2-Peptide Vaccination of Patients With Solid Tumors (HER2)

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ClinicalTrials.gov Identifier: NCT02276300
Recruitment Status : Unknown
Verified March 2016 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : October 28, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast or gastric cancer with moderate HER2/neu expression.

Condition or disease Intervention/treatment Phase
Gastric Cancer Breast Cancer Drug: Cyclophosphamide Drug: Sargramostim Drug: HER2-Peptid-Vakzine Drug: Imiquimod Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu
Study Start Date : December 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: HER2-Peptid-Vakzine, Cyclophosphamide
Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide
Drug: Cyclophosphamide
Treatment of mild Endoxan application three days before Her2 vaccination
Other Name: Endoxan

Drug: Sargramostim
Sargramostim is part of Her2 vaccination
Other Name: Leukine

Drug: HER2-Peptid-Vakzine
Her2 vaccination is supplemented by Sargramostim and Aldara Creme application

Drug: Imiquimod
Imiquimod is part of Her2 vaccination
Other Name: Aldara 5% Crème




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276300


Contacts
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Contact: Helen Bidner +49 89 4140 ext 6312 helen.bidner@mri.tum.de

Locations
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Germany
III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM Recruiting
Munic, Bavaria, Germany, 81675
Contact: Angela Krackhardt, Prof.Dr.med.    +49 89 4140 ext 4124    angela.krackhardt@lrz.tu-muenchen.de   
Principal Investigator: Angela Krackhardt, Prof.Dr.med.         
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Angela Krackhardt, Prof.Dr.med. III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02276300     History of Changes
Other Study ID Numbers: ATZ-1068-KRA-20I
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cyclophosphamide
Imiquimod
Vaccines
Sargramostim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic
Interferon Inducers