Clinical trial NCT00674791: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Immunotherapeutic vaccine
breast cancer
TxN2-3M0 breast cancer
metastatic breast cancer
immunotherapy
antigen
Histologically confirmed, TxN2-3M0 or metastatic breast cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Immunotope
First posted: 2008-05-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety/tolerability: Number of subjects with dose limiting toxicity after 3 immunizations.
timeFrame: Status post-3 immunizations
Secondary outcomes:
measure: Immunologic response: Number of subjects with tumor antigen specific immune response after 3 immunizations.
timeFrame: Status post-3 immunizations
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University Cancer Center
name: Michael Morse, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Cancer Center
name: Kimberly Blackwell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Immunotope
name: Ramila Philip, Ph.D.
References: