Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer

August 9, 2017 updated by: University of Pennsylvania

Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive

Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies try to assist a patient's immune system (a system in our bodies that protects us against infection) in killing tumors. One form of such therapy is the dendritic cell combined with HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are immune cells that can tell your immune system to fight infection. In laboratory testing, these cells may also help the immune system attack tumors such as breast, kidney cancer or skin cancer. The purpose of this research study is to determine if it is both possible and safe to administer" this vaccine to patients with any HER2+ cancer.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

We have demonstrated that administration of HER-2/neu pulsed DC1 in patients with DCIS results in strong immunologic responses as well as clinical responses during a brief 4 or 6 week neoadjuvant vaccination. In subsets of patients with cancer HER-2 is over-expressed including subsets of breast, gastric, pancreatic, brain, lung, and colon cancer. This trial is designed for compassionate use of a HER-2/neu pulsed DC1 in patients with metastatic HER-2 positive cancer, who have no longer standard options to eliminate disease.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Subjects with active metastatic HER-2 positive cancer, at least 1+ by IHC, that have already received standard therapy who have exhausted other treatment options.
  3. Subjects with HER-2 1+ need to be HLA 2 or HLA A3 positive. There are no HLA restrictions for HER-2 2+ or 3+.
  4. Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  5. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
  6. Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.

  7. Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

    -

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. Subjects with positive HIV or hepatitis C at baseline by self report.
  3. Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec
  4. Subjects with major cardiac illness MUGA or ECHO < 50% EF.
  5. Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
  6. Subjects receiving current therapy that may suppress immune system, such as steroids, chemotherapy at the discretion of the PI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25914

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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