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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084383 |
RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy together with chemotherapy and radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: GVAX pancreatic cancer vaccine Drug: fluorouracil Procedure: adjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas |
Study Start Date: | January 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Treatment continues in the absence of unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients 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 invasive ductal adenocarcinoma of the head, neck, and uncinate process of the pancreas
Has undergone pancreaticoduodenectomy at the Johns Hopkins Hospital within the past 8-10 weeks
No diagnosis other than ductal adenocarcinoma, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Immunologic
No prior or concurrent autoimmune disease requiring treatment with systemic immunosuppressants, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 |
Principal Investigator: | Daniel A. Laheru, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000361806, JHOC-J9988 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00084383 |
Health Authority: | United States: Federal Government |
stage I pancreatic cancer stage II pancreatic cancer duct cell adenocarcinoma of the pancreas |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Carcinoma Digestive System Diseases Fluorouracil |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |