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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

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ClinicalTrials.gov Identifier: NCT00674791
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
Immunotope
Information provided by:
Duke University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: OCPM Immunotherapeutic Vaccine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Safety/tolerability: Number of subjects with dose limiting toxicity after 3 immunizations. [ Time Frame: Status post-3 immunizations ]

Secondary Outcome Measures :
  1. Immunologic response: Number of subjects with tumor antigen specific immune response after 3 immunizations. [ Time Frame: Status post-3 immunizations ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674791


Locations
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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Immunotope
Investigators
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Principal Investigator: Michael Morse, M.D. Duke University Cancer Center
Principal Investigator: Kimberly Blackwell, M.D. Duke University Cancer Center
OverallOfficial: Ramila Philip, Ph.D. Immunotope

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Responsible Party: Ramila Philip, Ph.D., Immunotope, Inc.
ClinicalTrials.gov Identifier: NCT00674791     History of Changes
Other Study ID Numbers: Pro00000902
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: March 2011

Keywords provided by Duke University:
Immunotherapeutic vaccine
breast cancer
TxN2-3M0 breast cancer
metastatic breast cancer
immunotherapy
antigen
Histologically confirmed, TxN2-3M0 or metastatic breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs