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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety/tolerability: Number of subjects with dose limiting toxicity after 3 immunizations.

Outcome Time Frame:

Status post-3 immunizations

Safety Issue:

Yes

Principal Investigator

Michael Morse, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

Pro00000902

NCT ID:

NCT00674791

Start Date:

June 2007

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • Immunotherapeutic vaccine
  • breast cancer
  • TxN2-3M0 breast cancer
  • metastatic breast cancer
  • immunotherapy
  • antigen
  • Histologically confirmed, TxN2-3M0 or metastatic breast cancer
  • Breast Neoplasms

Name

Location
Duke Comprehensive Cancer Center Durham, North Carolina  27710