Spots Global Cancer Trial Database for 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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT00674791

Conditions

Breast Cancer

Interventions

OCPM Immunotherapeutic Vaccine

Study Description

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.