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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: | NCT00128622 |
RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to the cancer cells. Vaccines made from a gene-modified virus and a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving denileukin diftitox together with vaccine therapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects of giving denileukin diftitox together with vaccine therapy in treating patients with metastatic cancer that expresses carcinoembryonic antigen.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: denileukin diftitox Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine Drug: therapeutic autologous dendritic cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of Regulatory T Cell Depletion With Denileukin Diftitox Followed by Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox-Tricom in Patients With Advanced or Metastatic Malignancies Expressing CEA |
Estimated Enrollment: | 12 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). PBMCs are cultured with sargramostim (GM-CSF) and interleukin-4 for the production of dendritic cells( DC). DC are mixed with recombinant fowlpox-TRICOM to produce the vaccine. Patients are assigned to 1 of 2 cohorts according to timing of study enrollment.
In both cohorts, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed annually for up to 15 years.
PROJECTED ACCRUAL: A total of 6-12 patients (6 per cohort) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy
Tumor expresses carcinoembryonic antigen (CEA), as evidenced by any of the following:
Received or refused prior therapy with a possible survival or palliative benefit AND meets the following disease-specific criteria:
Patients with colorectal cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:
Patients with breast cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:
Patients with lung cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:
Patients with other malignancies must have experienced disease progression after prior first-line therapy that would confer a survival or palliative benefit, if such a therapy exists
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
No active acute or chronic viral hepatitis
Renal
Cardiovascular
Immunologic
No history of autoimmune disease*, including, but not limited to, the following:
No active cytomegalovirus (CMV) disease
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
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: | CDR0000437795, DUMC-NCI-7042, NCI-7042 |
Study First Received: | August 8, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00128622 |
Health Authority: | United States: Federal Government |
male breast cancer recurrent breast cancer stage IV breast cancer recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
recurrent pancreatic cancer extensive stage small cell lung cancer recurrent non-small cell lung cancer recurrent small cell lung cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific stage IV pancreatic cancer |
Thoracic Neoplasms Metronidazole Rectal Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Rectal Diseases Respiratory Tract Diseases Lung Neoplasms Neoplasm Metastasis Rectal cancer Breast Diseases Endocrine Gland Neoplasms Non-small cell lung cancer Digestive System Neoplasms |
Skin Diseases Endocrine System Diseases Breast Neoplasms Intestinal Diseases Intestinal Neoplasms Recurrence Rectal neoplasm Carcinoma, Small Cell Digestive System Diseases Breast Neoplasms, Male Interleukin-2 Denileukin diftitox Lung Diseases Gastrointestinal Neoplasms Pancreatic Diseases |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |