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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00085241 |
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells.
Combining vaccine therapy and radiation therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving vaccine therapy together with radiation therapy works in treating patients with carcinoembryonic antigen-positive solid tumors that have metastasized to the liver.
| Condition | Intervention |
|---|---|
|
Breast Cancer Colorectal Cancer Lung Cancer Metastatic Cancer Pancreatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Biological: recombinant fowlpox GM-CSF vaccine adjuvant Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine Biological: recombinant vaccinia-CEA(6D)-TRICOM vaccine Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Trial Of A CEA-Tricom Based Vaccine And Radiation To Liver Metastasis In Adults With CEA Positive Solid Tumors |
| Estimated Enrollment: | 16 |
| Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive a priming vaccination of vaccinia (rV)-CEA-TRICOM and recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine subcutaneously (SC) on day
1. Patients receive a booster vaccination of fowlpox (rF)-CEA-TRICOM and rF-GM-CSF SC on days 21, 35, 49, and 63. Patients undergo radiotherapy on days 22-25, 36-39, 50-53, and 64-67. Patients with stable disease or objective response after day 91 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed annually for 15 years.
PROJECTED ACCRUAL: A total of 16 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:
Diagnosis of solid tumor
Carcinoembryonic antigen (CEA)-positive disease that meets one of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
No chronic liver disease, including the following:
Renal
Cardiovascular
Pulmonary
Immunological
No autoimmune disease, including the following:
Other
During and for at least 3 weeks after vaccinia vaccination, patients or their close household contacts must not have contact with the following individuals:
Individuals with acute, chronic, or exfoliative skin disorders, including any of the following until the condition resolves:
No concurrent serious medical illness that would preclude study compliance, including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | James Gulley, MD, PhD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000367490, NCI-04-C-0167, NCI-6368 |
| Study First Received: | June 10, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00085241 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
liver metastases unspecified adult solid tumor, protocol specific recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the lung |
adenocarcinoma of the pancreas adenocarcinoma of the rectum recurrent pancreatic cancer recurrent non-small cell lung cancer stage IV non-small cell lung cancer recurrent breast cancer stage IV breast cancer stage IV pancreatic cancer |
|
Thoracic Neoplasms Metronidazole Rectal Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Pancrelipase Rectal Diseases Respiratory Tract Diseases Lung Neoplasms Neoplasm Metastasis Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Skin Diseases |
Adjuvants, Immunologic Rectal Neoplasm Breast Neoplasms Endocrine System Diseases Intestinal Diseases Intestinal Neoplasms Recurrence Rectal Cancer Digestive System Diseases Lung Diseases Non-small Cell Lung Cancer Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma of Lung |
|
Thoracic Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Rectal Diseases Neoplastic Processes Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Neoplasm Metastasis Breast Diseases Endocrine Gland Neoplasms |
Respiratory Tract Neoplasms Digestive System Neoplasms Skin Diseases Endocrine System Diseases Breast Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Digestive System Diseases Lung Diseases Gastrointestinal Neoplasms Pancreatic Diseases Colorectal Neoplasms |