HER2-Peptide Vaccination of Patients With Solid Tumors

NCT02276300 | Completed Phase 1

• 1 other identifier: ATZ-1068-KRA-20I
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Safety measurement will be assessed up to 113 days relating to start of study treatment

Study Arms (1)

HER2-Peptid-Vakzine, Cyclophosphamide

EXPERIMENTAL

Her2-peptide vaccination, Sargramostim, Imiquimod, Cyclophosphamide

Drug: Cyclophosphamide; Drug: Sargramostim; Drug: HER2-Peptid-Vakzine; Drug: Imiquimod

Interventions

Cyclophosphamide DRUG

Treatment of mild Endoxan application three days before Her2 vaccination

Also known as: Endoxan

HER2-Peptid-Vakzine, Cyclophosphamide

Sargramostim DRUG

Sargramostim is part of Her2 vaccination

Also known as: Leukine

HER2-Peptid-Vakzine, Cyclophosphamide

HER2-Peptid-Vakzine DRUG

Her2 vaccination is supplemented by Sargramostim and Aldara Creme application

HER2-Peptid-Vakzine, Cyclophosphamide

Imiquimod DRUG

Imiquimod is part of Her2 vaccination

Also known as: Aldara 5% Crème

HER2-Peptid-Vakzine, Cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms; Breast Neoplasms

Interventions

Cyclophosphamide; sargramostim; Imiquimod

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Angela Krackhardt, Prof.Dr.med.

  III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 28, 2014
• Study Start: December 1, 2014
• Primary Completion: July 18, 2017
• Study Completion: July 13, 2018
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

DE (1)