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Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201


OBJECTIVES:

Primary

- Determine the efficacy of multiepitope autologous dendritic cell vaccine, trastuzumab
(Herceptin^®), and vinorelbine by measuring the change in the largest dimension of
metastatic lesions, in women with locally recurrent or metastatic breast cancer that
does not overexpress HER2/neu.

Secondary

- Determine the ability of this regimen to induce functional antigen-specific T cells in
these patients by measuring ex-vivo antigen-specific T-cell activity against
peptide-pulsed dendritic cells and tumor targets by tetramer staining and intracellular
cytokine assays.

OUTLINE:

- Autologous dendritic cell mobilization and harvest: All patients undergo autologous
dendritic cell mobilization with filgrastim (G-CSF) and/or sargramostim (GM-CSF)
subcutaneously daily for 4 days followed by apheresis. Mobilized peripheral blood is
processed for the production of dendritic cells by CD34-positive cell selection. The
dendritic cells are expanded and then pulsed with E75 and E90 peptides.

- Treatment: Patients receive vinorelbine IV over 6-10 minutes and trastuzumab (Herceptin
^®) IV over 90 minutes on day 1. Patients also receive autologous dendritic cells
pulsed with E75 and E90 peptides subcutaneously over 2-5 minutes on day 1*. Treatment
repeats every 14 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

NOTE: *If treatment is given locally, the vaccine therapy will be given at UNC-Chapel Hill
the following day.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed breast cancer

- Locally recurrent or metastatic disease

- HLA-A0201 positive by DNA genotyping

- HER2/neu expression at least 1+ by immunohistochemistry of tumor sample

- CNS metastases allowed provided on therapy for 3 months and stable

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hematocrit > 33%

Hepatic

- Transaminases ≤ 3 times upper limit of normal

- Bilirubin ≤ 2 times normal

- Hepatitis B surface antigen negative

Renal

- Creatinine < 2.0 mg/dL

Cardiovascular

- Ejection fraction > 45% by MUGA OR

- Left ventricular function normal by echocardiogram

- No serious cardiac condition that would preclude study participation or compliance

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No serious medical or psychiatric condition that would preclude study participation
or compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior biologic therapy allowed

Chemotherapy

- More than 30 days since prior cytotoxic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- More than 30 days since prior hormonal therapy

- No concurrent hormonal therapy

- No concurrent systemic steroids

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- Concurrent bisphosphonates for bone metastases allowed

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Response measured by RECIST criteria

Outcome Time Frame:

6 months following treatment

Safety Issue:

No

Principal Investigator

Jonathan S. Serody, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LCCC 0310

NCT ID:

NCT00088985

Start Date:

January 2004

Completion Date:

Related Keywords:

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

Name

Location

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