Study of Cancer Peptides Vaccine Plus GM-CSF as Adjuvant Treatment for High Risk (TXN2-3M0) or Metastatic Breast Cancer With No Evidence of Disease

NCT ID: NCT00674791

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-01-31

Brief Summary

This study will evaluate the safety and feasibility of administering a peptide vaccine consisting of twelve different tumor-rejection antigens to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.

Detailed Description

The primary endpoint will be to determine the safety and feasibility of administering cancer peptides to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy, with the secondary objectives of evaluating immune response disease relapse survival. Two cohorts of 9 patients each will be treated with different doses of the vaccine. They will receive the peptide vaccine subcutaneously on weeks 0,1,2,4,5, and 6 and then receive the immunizations every 1 month for 6 months or disease recurrence. Toxicity will be assessed at each dose level using CTCv3 toxicity criteria.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

OCPM Immunotherapeutic Vaccine

Patients will receive 1 injection into each thigh at each of 6 visits: week 0, week 1, week 2, week 4, week 5, and week 6. The first 9 patients will receive a 100 microgram dose and the second 9 patients a 1 milligram dose of the peptide mixture.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• HLA-A2 patients with histologically confirmed, TxN2-3M0 or metastatic breast cancer with no evidence of disease who have completed their adjuvant systemic chemotherapy or trastuzumab
• Subjects will not be treated until 4 or more weeks after any prior chemotherapy, radiation therapy or immunotherapy, but they may be receiving hormonal therapy

Exclusion Criteria

• History of autoimmune disease
• Serious intercurrent chronic or acute illness
• Active hepatitis
• Serologic evidence for HIV, splenectomy
• Receiving steroid or immunosuppressive therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunotope

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Immunotope, Inc.

Principal Investigators

Michael Morse, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University Cancer Center

Kimberly Blackwell, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University Cancer Center

Ramila Philip, Ph.D.

Role:

Immunotope

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00000902

Identifier Type: -

Identifier Source: org_study_id