Multipeptide Vaccine for Advanced Breast Cancer

NCT00573495 | Completed Phase 1 DMC

• 1 other identifier: UPCC 08107
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study on how to activate the immune system with a vaccine. The vaccine is made up of two proteins found in breast cancer: telomerase and survivin. The vaccine is given in combination with other drugs that may also have an effect on the immune system and attack the cancer. The goals of the study are:

1. 1.to test the safety of the combination of agents
2. 2.to find out what effects the treatment has on advanced breast cancer

Conditions

Breast Neoplasm; Breast Cancer; Cancer of the Breast; Carcinoma, Ductal

Keywords

Advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• Safety

  Up to 30 days after the last vaccination

Secondary Outcomes (1)

• Immunologic response

  After 4th vaccination, then after every 3-4 vaccinations, and then every 6 months

Study Arms (1)

hTERT/Survivin Multi-Peptide Vaccine

EXPERIMENTAL

Biological: hTERT/Survivin Multi-Peptide Vaccine

Interventions

hTERT/Survivin Multi-Peptide Vaccine BIOLOGICAL

100 mcg subcutaneous every 2 weeks four times, then monthly up to 28 vaccinations

Also known as: hTERT, Telomerase

hTERT/Survivin Multi-Peptide Vaccine

Eligibility Criteria

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

You may qualify if:

• Stage IV breast cancer that has failed at least one conventional therapy for metastatic disease
• HLA-A2 positive
• Measurable or evaluable disease
• ECOG performance status 0-1
• Negative contrast CT or MRI scan of the brain within 30 days of treatment
• Negative pregnancy test within 14 days of treatment for women of childbearing potential

You may not qualify if:

• History of brain metastases within the last 4 years
• The use of chemotherapy, radiation therapy, immunosuppressive drugs, systemic glucocorticoids, growth factors, or experimental therapy, and anti-coagulants within 14 days prior to treatment
• Initiation of hormonal agent in the 30 days before treatment
• Initiation of Herceptin in the 30 days prior to treatment.
• History of bone marrow or stem cell transplantation
• Pregnant or lactating

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19341, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal

Interventions

Telomerase

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

RNA-Directed DNA Polymerase; DNA-Directed DNA Polymerase; DNA Nucleotidyltransferases; Nucleotidyltransferases; Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Poly-ADP-Ribose Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Ribonucleoproteins; RNA-Binding Proteins; Nuclear Proteins; Nucleoproteins

Study Officials

• Kevin Fox, MD

  University of Pennsylvania

  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: December 12, 2007
• First Posted: December 14, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2013
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (1)