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

NCT02473653 | Unknown

• 1 other identifier: 25914
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer

Interventions

HER-2/neu Pulsed DC1 vaccine BIOLOGICAL

There will be no exceptions to eligibility, contraindicated treatment/therapies/interventions or safety tests.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Abramson Cancer Center at Penn Medicine: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 16, 2015
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

US (1)