Back to resultsPilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer
Primary Purpose
Metastatic Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
HER-2/neu Pulsed DC1 vaccine
Sponsored by
About this trial
This is an expanded access trial for Metastatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- 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.
- 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+.
- Women of childbearing age with a negative pregnancy test documented prior to enrollment.
- Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
- 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.
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:
- Pregnant or lactating females.
- Subjects with positive HIV or hepatitis C at baseline by self report.
- Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec
- Subjects with major cardiac illness MUGA or ECHO < 50% EF.
- Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
- Subjects receiving current therapy that may suppress immune system, such as steroids, chemotherapy at the discretion of the PI.
Sites / Locations
- Hospital of the University of Pennsylvania
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02473653
First Posted
June 4, 2015
Last Updated
August 9, 2017
Sponsor
University of Pennsylvania
Collaborators
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02473653
Brief Title
Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer
Official Title
Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Abramson Cancer Center at Penn Medicine
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
HER-2/neu Pulsed DC1 vaccine
Intervention Description
There will be no exceptions to eligibility, contraindicated treatment/therapies/interventions or safety tests.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
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.
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+.
Women of childbearing age with a negative pregnancy test documented prior to enrollment.
Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
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.
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:
Pregnant or lactating females.
Subjects with positive HIV or hepatitis C at baseline by self report.
Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec
Subjects with major cardiac illness MUGA or ECHO < 50% EF.
Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
Subjects receiving current therapy that may suppress immune system, such as steroids, chemotherapy at the discretion of the PI.
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer
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