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Phase II Trial Evaluating the Toxicity and Efficacy of a Multiepitope Dendritic Cell Vaccine Given With Trastuzumab and Vinorelbine Ditartrate for the Treatment of Women With Metastatic Breast Cancer That Express HLA-A0201 and Whose Tumors Overexpress HER-2/NEU


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Phase II Trial Evaluating the Toxicity and Efficacy of a Multiepitope Dendritic Cell Vaccine Given With Trastuzumab and Vinorelbine Ditartrate for the Treatment of Women With Metastatic Breast Cancer That Express HLA-A0201 and Whose Tumors Overexpress HER-2/NEU


OBJECTIVES:

Primary

- Determine the efficacy of multiepitope autologous dendritic cell vaccine in combination
with trastuzumab (Herceptin®) and vinorelbine ditartrate in patients with locally
recurrent or metastatic breast cancer whose tumors overexpress HER2/neu.

Secondary

- Determine if this regimen is effective in generating functional antigen-specific T
cells.

OUTLINE:

- Therapeutic autologous dendritic cell (DC) preparation: Patients undergo mobilization
of DC and apheresis for production of therapeutic DC. DCs are expanded in vitro for
10-20 days and pulsed with E75 and E90 peptides.

- Treatment: Patients receive vinorelbine ditartrate IV over 6-10 minutes, therapeutic
autologous DC intradermally over 2-5 minutes, and trastuzumab (Herceptin®) IV over
30-90 minutes on day 1. Patients receive sargramostim (GM-CSF) subcutaneously on days
2, 4, and 6, or until neutrophil counts recover. Treatment repeats every 14 days for up
to 6 courses (or more at the discretion of the investigator) in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Inclusion Criteria


PATIENT ELIGIBILITY

4.1 Inclusion Criteria 4.1.1 Histologically proven metastatic breast cancer with
measurable or evaluable disease per investigator discretion.

4.1.2 Patients must be 18 years of age or older. Women of child bearing potential must be
practicing barrier or oral contraception for the duration of the study, or documented as
surgically sterile or one year post-menopausal.

4.1.3 ECOG performance status 0-2 (See Appendix A).

4.1.5 Cardiac function by MUGA with an EF > 45% or an echocardiogram that shows normal LV
function.

4.1.6 Serum Creatinine < 2.0 mg/dl. 4.1.7 Hepatic transaminases (alanine aminotransferase
(ALT) and aspartate aminotransferase (AST)) ≤3.0 times the upper limit of normal if no
liver metastases or ≤5 times the upper limit of normal if liver metastases are present.

4.1.8 Bilirubin no more than 2X normal.

4.1.9 Seronegative for HIV.

4.1.10 Negative for Hepatitis B surface antigen.

4.1.11 Signed and dated informed consent.

4.1.12 HLA A0201+ by DNA genotyping.

4.1.13 Absolute neutrophil count greater than 1,500/mm3. Platelet count greater
100,000/mm3 and hemoglobin greater than or equal to 10

4.1.14. 3+ expression of HER-2/neu from original pathology (diagnostic) tumor sample by
IHC or 2+ expression by IHC with gene amplification by FISH.

4.1.15. Patients will be eligible even if they have failed treatment for metastatic breast
cancer with trastuzumab and a chemotherapy agent other than vinorelbine or if they have
progressed within 12 months of receiving adjuvant chemotherapy using trastuzumab and a
taxane.

4.2 Exclusion Criteria

4.2.1 Patients with any serious medical, cardiac, or psychiatric condition which, in the
opinion of the investigator, would make the patient unsuitable for study participation or
would impede probable compliance with the protocol.

4.2.2 Patients with central nervous system metastases must have stable disease for at
least 3 months prior to study entry.

4.2.3 Patient is currently taking steroid medications. Systemic steroid treatment is not
allowed.

4.2.4 Patients that have failed prior therapy with vinorelbine + trastuzumab will not be
eligible for therapy.

4.2.5 Patient has received hormonal or cytotoxic chemotherapy within 14 days of apheresis
and within 28-30 days prior to study treatment.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Outcome Time Frame:

5-6 years

Safety Issue:

No

Principal Investigator

Jonathan S. Serody, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

LCCC 0418

NCT ID:

NCT00266110

Start Date:

December 2005

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570