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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027534 |
Purpose
RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colorectal Cancer Gallbladder Cancer Gastric Cancer Head and Neck Cancer Liver Cancer Ovarian Cancer Pancreatic Cancer Testicular Germ Cell Tumor |
Biological: CMV pp65 peptide Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine Biological: tetanus toxoid Biological: therapeutic autologous dendritic cells |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity.
Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 6-18 patients 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:
Histologically confirmed advanced or metastatic malignancy expressing CEA
Metastatic disease meeting one of the following criteria:
History of metastases but no current evidence of disease, meeting one of the following criteria:
Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%)
CEA-expressing malignancy is defined by any of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No history of autoimmune disease, including, but not limited to, the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27705 | |
| Study Chair: | Herbert K. Lyerly, MD | Duke University |
More Information
| Study ID Numbers: | CDR0000069041, DUMC-2840-02-6R1, NCI-1864 |
| Study First Received: | December 7, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027534 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent colon cancer stage III colon cancer stage IV colon cancer recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent gastric cancer stage III gastric cancer stage IV gastric cancer recurrent pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer recurrent rectal cancer |
stage III rectal cancer stage IV rectal cancer advanced adult primary liver cancer recurrent adult primary liver cancer recurrent gallbladder cancer unresectable gallbladder cancer thyroid gland medullary carcinoma recurrent salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer Paget disease of the breast with intraductal carcinoma Paget disease of the breast with invasive ductal carcinoma adult primary hepatocellular carcinoma diffuse adenocarcinoma of the stomach intestinal adenocarcinoma of the stomach |
|
Gallbladder Diseases Liver Diseases Gonadal Disorders Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Ovarian Diseases Rectal Diseases Genital Diseases, Female Liver Neoplasms Stomach Diseases Neoplasms by Site Neoplasms, Germ Cell and Embryonal Stomach Neoplasms |
Biliary Tract Diseases Breast Diseases Endocrine Gland Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Biliary Tract Neoplasms Skin Diseases Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Intestinal Diseases Intestinal Neoplasms Adnexal Diseases Neoplasms |