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| Sponsored by: |
University of Washington |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003002 |
Purpose
RATIONALE: Vaccines made from the HER2/neu antigen may make the body build an immune response and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of HER-2/neu vaccine plus GM-CSF in treating patients who have stage III or stage IV breast cancer, stage III or stage IV ovarian cancer, or stage III or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Lung Cancer Ovarian Cancer |
Drug: HER-2/neu peptide vaccine Drug: sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of a HER-2/Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2/Neu Expressing Cancers |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 1996 |
OBJECTIVES: I. Determine the safety of serial intradermal vaccinations of HER-2/neu derived peptides with sargramostim (GM-CSF) as an adjuvant in patients with stage III or IV HER-2/neu expressing breast, ovarian, or nonsmall cell lung cancer. II. Determine whether immunity can be elicited with peptides derived from the intracellular domain of the HER-2/neu protein. III. Determine whether immunity can be elicited with peptides derived from the extracellular domain of the HER-2/neu protein. IV. Determine whether cytotoxic T cells specific for the HER-2/neu protein can be elicited in patients with HLA-A2 by immunization with peptides derived from the HER-2/neu protein.
OUTLINE: Patients receive one of three HER-2/neu peptide vaccine formulations that also contain sargramostim (GM-CSF) as the vaccine adjuvant. Each vaccine is studied in 20 patients. A maximum of 3 patients receive a vaccine each month for 6 months to monitor the potential toxicity associated with sequential immunizations. Patients receive a follow-up evaluation 1 month after the last vaccination. Those patients who have an immune response related to the vaccine will continue to have immunologic evaluations performed every 2 months while immune responses can still be detected.
PROJECTED ACCRUAL: 60 patients will be accrued.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage III or IV breast, ovarian, or nonsmall cell lung cancer (NSCLC): Adenocarcinoma No progressive disease May have comlpeted at least 1 standard chemotherapy regimen Confirmed HER-2/neu protein overexpression in tumor (either primary tumor or metastasis)
PATIENT CHARACTERISTICS: Age: Pre or postmenopausal Performance status: Not specified 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 Creatinine clearance greater than 60 mL/min Other: No anergy (positive delayed type hypersensitivity response required to two or more common recall antigens) Female patients must be nonfertile Male patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 1 month since cytotoxic chemotherapy Endocrine therapy: At least 1 month since corticosteroid therapy Concurrent hormone therapy allowed Radiotherapy: Concurrent radiation therapy for local control of disease allowed (except as initial therapy for NSCLC) Surgery: Not specified
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
| Study ID Numbers: | CDR0000065564, UW-100.1, NCI-V97-1259 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003002 |
| Health Authority: | United States: Federal Government |
|
stage III breast cancer stage IV breast cancer stage III non-small cell lung cancer stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
|
Thoracic Neoplasms Ovarian cancer Non-small cell lung cancer Ovarian Neoplasms Skin Diseases Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Carcinoma Genital Diseases, Female Adenocarcinoma of lung Respiratory Tract Diseases Lung Neoplasms Lung Diseases Endocrinopathy Adenocarcinoma Carcinoma, Non-Small-Cell Lung Breast Diseases Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Adnexal Diseases |
