A Phase I Vaccine Trial of a HER-2/Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers
18 Years
N/A
Both
Breast Cancer, Lung Cancer, Ovarian Cancer
Trial Information
A Phase I Vaccine Trial of a HER-2/Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers
OBJECTIVES: I. Determine the safety of serial intradermal or subcutaneous vaccinations of
HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres
with adjuvant sargramostim (GM-CSF) in patients with stage III or IV HER-2 expressing
cancers. II. Determine whether cytotoxic T lymphocytes (CTL) specific for the HER-2 protein
can be elicited in patients with HLA-A2 by immunization with this regimen. III. Determine
which route of immunization, intradermal or subcutaneous, is more effective in generating
HER-2 specific CTL in these patients on this regimen. IV. Determine the extent to which
escalated dose of PLG peptide affects the immune response in these patients on this regimen.
OUTLINE: Patients undergo leukapheresis prior to study and after final vaccination. Patients
are sequentially entered into one of three treatment arms: Arm I: Patients receive an
intradermal vaccination of HER-2 derived p369-377 peptide incorporated into
polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF). Arm II:
Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated
into PLG microspheres with adjuvant GM-CSF. Arm III: Patients receive a higher dose of
subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG
microspheres with adjuvant GM-CSF. Treatment repeats every 4 weeks for up to 6 courses in
the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15 patients (5 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Stage III adenocarcinoma that overexpresses HER-2 and previously
treated by surgical resection, conventional chemotherapy, or radiotherapy OR Stage IV
adenocarcinoma that overexpresses HER-2 and in stable or complete remission with no other
concurrent chemotherapy Must have documented HER-2 protein overexpression in the primary
or metastatic tumor HLA-A2 positive
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 90-100% Life
expectancy: At least 12 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less
than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Female patients must
have completed childbearing Fertile male patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy: At
least 4 weeks since prior corticosteroids Radiotherapy: See Disease Characteristics
Surgery: See Disease Characteristics Other: No other concurrent investigational phase I
studies
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mary (Nora) L. Disis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Washington
Authority:
United States: Federal Government
Study ID:
CDR0000067339
NCT ID:
NCT00005023
Start Date:
March 1999
Completion Date:
January 2001
Related Keywords:
- Breast Cancer
- Lung Cancer
- Ovarian Cancer
- stage IV breast cancer
- stage IIIA breast cancer
- stage III non-small cell lung cancer
- stage IIIB breast cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- stage IV non-small cell lung cancer
- adenocarcinoma of the lung
- Breast Neoplasms
- Lung Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| University of Washington School of Medicine | Seattle, Washington 98195 |
