|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Washington |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005023 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Lung Cancer Ovarian Cancer |
Biological: HER-2/neu peptide vaccine Biological: sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
| Study Start Date: | March 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195 | |
| Study Chair: | Mary (Nora) L. Disis, MD | University of Washington |
More Information
| ClinicalTrials.gov Identifier: | NCT00005023 History of Changes |
| Other Study ID Numbers: | CDR0000067339, UWASH-103, NCI-V99-1574 |
| Study First Received: | April 6, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
