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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005956 |
RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Gastric Cancer Ovarian Cancer |
Drug: HER-2/neu intracellular domain protein Drug: therapeutic autologous dendritic cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced malignancy that expresses HER2/neu
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Immunologic:
Must have positive intradermal delayed hypersensitivity test for at least 1 of the following:
No prior autoimmune disease including, but not limited to, the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Michael A. Morse, MD | Duke University |
Study ID Numbers: | CDR0000067937, DUMC-1309-00-7R1, DUMC-1528-99-9, NCI-G00-1800 |
Study First Received: | July 5, 2000 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00005956 |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IV breast cancer stage IIIA breast cancer stage II gastric cancer stage III gastric cancer |
stage IV gastric cancer stage IIIB breast cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Skin Diseases Gonadal Disorders Gastrointestinal Diseases Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Stomach cancer Urogenital Neoplasms |
Ovarian Diseases Ovarian epithelial cancer Genital Diseases, Female Digestive System Diseases Stomach Diseases Stomach Neoplasms Gastrointestinal Neoplasms Endocrinopathy Breast Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |