Vaccination Against High Risk Breast Cancer Using Tumor Derived Heat Shock Protein 70

NCT00027131 | Terminated Phase 1

• 1 other identifier: 01-062
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Description: The trial is designed to determine the response of the immune system of patients with breast cancer to a vaccine made from their own tumor. Researchers believe that this particular vaccine, which is made from purified heat shock proteins taken from each patient's tumor, might alert the body's immune system to recognize and attack invading cancer. To be considered potentially eligible for this study you must be a high risk breast cancer patient and have a tumor that can be removed surgically. Length/Duration: Vaccinations are administered weekly for six weeks. Follow up visits to the clinic are every three months for two years, then every six months thereafter.

Conditions

Breast Neoplasms

Keywords

vaccine; immunotherapy

Interventions

Heat Shock Protein 70-peptide complexes (HSP70) BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Must be at least 18 years of age and capable of giving informed consent.
• High risk breast cancer defined as the following:
• stage IV breast cancer
• inflammatory breast carcinoma
• Stage II breast cancer with more than 10 positive axillary lymph nodes
• Stage IIIA breast cancer (tumor greater than or equal to 5 cm with at least one positive axillary lymph note)
• A minimum of 3 grams of non-necrotic, resectable breast cancer.
• ECOG Performance Score (PS) less than (\<3.0).

You may not qualify if:

• ECOG Performance Score (PS) greater than or equal to 3.0.
• Congenital or acquired immunodeficiency including infection with human immunodeficiency virus.
• Significant behavioral or psychological problems that preclude adequate informed consent or follow-up.
• Major clinical responses defined as either Complete response (CR) by conventional staging work-up such as CT scan and bone scan.
• Or Stable partial response (PR) defined as more than 50% tumor reduction which remains stable by serial CT scans or bone scans over a 3-month span.
• More than 60 micrograms of HSP70 purified.
• ECOG Performance Score(PS) less than 3.0.
• Greater than or equal to 4 weeks post cytotoxic therapy.
• ECOG Performance Score(PS) greater than or equal to 3.0.
• Purification of HSP70 is unsuccessful qualitatively or quantitatively.
• On other investigational therapy for breast cancer.
• Positive serum or urine pregnancy test.
• Impaired renal function (serum creatinine \> 2.0) and hepatic function (bilirubin more than 2.0 x and transaminase more than 4.0 x of the upper normal limit).
• Significant active infection requiring hospitalization;
• Acquired immunodeficiency or active autoimmune diseases.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Links

• UConn web page

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zihai Li, MD, P.hD.

  Assistant Professor Medicine & Tumor Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2001
• First Posted: November 28, 2001
• Study Start: December 1, 2000
• Study Completion: October 1, 2002
• Last Updated: October 8, 2008

Record last verified: 2008-10

Locations

US (1)