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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: | NCT00305760 |
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Biological: cetuximab Biological: sargramostim plasmid DNA pancreatic tumor cell vaccine Drug: cyclophosphamide Other: laboratory biomarker analysis Procedure: biopsy |
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 Erbitux (Cetuximab) for the Treatment of Advanced Pancreatic Adenocarcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive cyclophosphamide IV on day 0, sargramostim plasmid DNA pancreatic tumor cell vaccine intradermally on day 1, and cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection and tumor biopsies periodically during study for biomarker correlative studies.
At the completion of study treatment, patients are followed at 3 weeks and then every 4 weeks for 16 weeks.
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 ductal adenocarcinoma of the pancreas
The following histologic diagnoses are not eligible:
Measurable disease defined as ≥ 1 lesion unidimensionally measured as ≥ 20 mm by conventional techniques or
10 mm by spiral CT scan
No nonmeasurable disease only including, but not limited to, the following:
PATIENT CHARACTERISTICS:
No active autoimmune disease or prior autoimmune disease requiring medical treatment with systemic immunosuppressants including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent systemic steroids or immunosuppressive drugs
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Principal Investigator: | Daniel A. Laheru, MD | Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Daniel A. Laheru ) |
Study ID Numbers: | CDR0000463380, JHOC-J0501, JHOC-05021103, JHOC-05042610, BMS-CA225247 |
Study First Received: | March 21, 2006 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00305760 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage III pancreatic cancer recurrent pancreatic cancer duct cell adenocarcinoma of the pancreas adenocarcinoma of the pancreas stage IV pancreatic cancer |
Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Cetuximab Endocrine System Diseases Cyclophosphamide Immunosuppressive Agents Pancrelipase Recurrence Carcinoma |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Antineoplastic Agents, Alkylating Endocrinopathy Antirheumatic Agents Adenocarcinoma Alkylating Agents Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Cyclophosphamide Neoplasms by Site Therapeutic Uses Alkylating Agents Endocrine Gland Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Cetuximab |
Endocrine System Diseases Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Myeloablative Agonists Pancreatic Diseases Antineoplastic Agents, Alkylating Adenocarcinoma Antirheumatic Agents Neoplasms, Glandular and Epithelial |