Study of Combination Immunotherapy for the Generation of HER-2/Neu Specific Cytotoxic T Cells

This study has been completed.
Sponsor:
Collaborator:
Cancer Treatment Research Foundation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00194714
First received: September 13, 2005
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

This will be a single arm phase I-II single institution clinical trial in patients with HER2 overexpressing Stage IV breast and ovarian cancer who are on maintenance trastuzumab alone after being treated with chemotherapy and trastuzumab or trastuzumab alone to NED or stable disease. Patients will receive a monthly vaccination for 6 months with a HER2 CTL peptide-based vaccine.


Condition Intervention Phase
Breast Cancer
Biological: HER2 CTL vaccine (plus trastuzumab)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study of Combination Immunotherapy for the Generation of HER-2/Neu (HER2) Specific Cytotoxic T Cells (CTL) in Vivo

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Immune response [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: At least 5 years ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: June 2004
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HER2 CTL peptide-based vaccine; administered intradermally every month for 6 total doses
Biological: HER2 CTL vaccine (plus trastuzumab)
HER2 CTL peptide-based vaccine; administered intradermally every month for 6 total doses

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have either Stage IV breast or ovarian cancer in remission or with stable disease on trastuzumab monotherapy.
  2. HER2 overexpression by immunohistocytochemistry (IHC) of 2+ or 3+, in the primary tumor or metastasis. If overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH.
  3. Subjects must be HLA-A2 positive.
  4. Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and any immunosuppressive agents such as systemic steroids for at least 30 days prior to enrollment. Patients should continue trastuzumab monotherapy throughout the course of this protocol. Concurrent hormonal and biphosphonate therapies are allowed.
  5. Subjects must have an ECOG Performance Status Score = 0 or 1 (Appendix A)
  6. Male subjects must agree to contraceptive use during the study period (7 months) and non-menopausal female subjects must agree to contraception for the remainder of their childbearing years. (HER2 is overexpressed in normal fetal tissues. Therefore, induction of long-term immunity to overexpressed HER2 could affect the viability of a future fetus.)
  7. Subjects must have a hematocrit greater than 30, a platelet count greater than 100,000, and a WBC greater than 3000/µl. Laboratory tests should be performed within 60 days of enrollment.
  8. Age older than18 years
  9. Stable creatinine less than 2.0mg/dL, or creatinine clearance greater than 60ml/min. Laboratory tests should be performed within 60 days of enrollment.
  10. Serum bilirubin less than 1.5 mg/dl. Laboratory tests should be performed within 60 days of enrollment.
  11. SGOT less than 2x ULN. Laboratory tests should be performed within 60 days of enrollment.
  12. Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival.
  13. Patients must have a baseline LVEF measured by MUGA equal to or greater than the lower limit of normal for the radiology facility and if there are two consecutive MUGAS performed while on trastuzumab from the same radiology facility, there can not be a decrease in LVEF of greater than 15% from the original MUGA scan.

Exclusion Criteria:

  1. Subjects cannot be simultaneously enrolled on other treatment studies.
  2. Any contraindication to receiving GM-CSF based vaccine products.
  3. Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion.
  4. Active autoimmune disease.
  5. Subjects can not have an active immunodeficiency disorder, e.g. HIV
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00194714

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
Cancer Treatment Research Foundation
Investigators
Principal Investigator: Mary L Disis, M.D. University of Washington
  More Information

Additional Information:
No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary L. (Nora) Disis, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00194714     History of Changes
Other Study ID Numbers: 6304, G-04-003
Study First Received: September 13, 2005
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Breast cancer
Stage IV
HER2/neu+

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014