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Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
This study has been completed.
Study NCT00005023   Information provided by National Cancer Institute (NCI)
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes

April 6, 2000
February 6, 2009
March 1999
 
 
 
Complete list of historical versions of study NCT00005023 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
A Phase I Vaccine Trial of a HER-2/Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers

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.

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.

Phase I
Interventional
Treatment
  • Breast Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Biological: HER-2/neu peptide vaccine
  • Biological: sargramostim
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005023
 
CDR0000067339, UWASH-103, NCI-V99-1574
University of Washington
 
Study Chair: Mary (Nora) L. Disis, MD University of Washington
National Cancer Institute (NCI)
July 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP