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A Phase I Vaccine Trial of a HER-2/Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer, Ovarian Cancer

Thank you

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 MedicineSeattle, Washington  98195