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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA 51) Following Completion of Prescribed Chemotherapy or Trastuzumab for TXN2-3M0 or Metastatic Breast Cancer With No Evidence of Disease

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: OCPM Immunotherapeutic Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability: Number of subjects with dose limiting toxicity after 3 immunizations. |  | Status post-3 immunizations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunologic response: Number of subjects with tumor antigen specific immune response after 3 immunizations. |  | Status post-3 immunizations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapeutic vaccine, breast cancer, TxN2-3M0 breast cancer, metastatic breast cancer, immunotherapy, antigen, Histologically confirmed, TxN2-3M0 or metastatic breast cancer