Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005023
• Other study ID #: CDR0000067339
• Secondary ID: UWASH-103NCI-V99
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2000
• Last updated: November 28, 2017
• Start date: March 1999
• Est. completion date: January 2001

Study information

• Verified date: November 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines may make the body build an immune response to tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer
• Lung Neoplasms
• Ovarian Cancer

Intervention

Biological:
• HER-2/neu peptide vaccine

• sargramostim

Locations

Country	Name	City	State
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States,