Vaccine Treatment for Surgically Resected Pancreatic Cancer
|First Received Date ICMJE||November 16, 2005|
|Last Updated Date||September 25, 2009|
|Start Date ICMJE||November 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To assess the side effects, dose-limiting toxicity and maximum tolerated dose. [ Time Frame: 6 months ]|
|Original Primary Outcome Measures ICMJE
||To assess the side effects, dose-limiting toxicity and maximum tolerated dose.|
|Change History||Complete list of historical versions of study NCT00255827 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To assess the rate of recurrence after treatment. [ Time Frame: 6 months ]|
|Original Secondary Outcome Measures ICMJE
||To assess the rate of recurrence after treatment.|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vaccine Treatment for Surgically Resected Pancreatic Cancer|
|Official Title ICMJE||A Phase I/II Study of an Antitumor Vaccination Using Alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Pancreatic Cancer|
This 2-phase study will determine the safety of treating patients with pancreatic cancer with the genetically engineered HyperAcute-Pancreatic cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed pancreatic cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink.
Patients 18 years of age or older with pancreatic cancer that has been surgically resected may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed.
Participants will receive twelve vaccinations two weeks apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the remaining first year (6 months) after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects:
Medical history and physical examination Blood tests X-rays and various scans (nuclear medicine/CT/MRI) FACT-Hep Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, monthly during treatment, and during follow-up visits after completing the treatment. It includes questions on the severity of pancreatic cancer symptoms and the ability to perform normal activities of daily life.
According to statistics of the American Cancer Society, an estimated 31,000 individuals will be diagnosed with pancreatic cancer and 25,000 will die of the disease, making it the fifth leading cause of U.S. cancer deaths this year despite all current therapy. This protocol attempts to exploit an approach to pancreatic cancer immunotherapy using a naturally occurring barrier to xenotransplantation in humans in an attempt to vaccinate patients against their pancreatic cancer. The expression of the murine alpha (1,3) galactosyltransferase [alpha (1,3) GT] gene results in the cell surface expression of alpha (1,3) galactosyl-epitopes (alpha-gal) on membrane glycoproteins and glycolipids. These epitopes are the major target of the hyperacute rejection response that occurs when organs are transplanted from non-primate donor species into man. Human hosts often have pre-existing anti-alpha-gal antibodies that bind alpha-gal epitopes and lead to rapid activation of complement and cell lysis. The pre-existing anti-alpha-gal antibodies found in most individuals are thought to be due to exposure to alpha-gal epitopes that are naturally expressed on normal gut flora leading to chronic immunological stimulation. These antibodies may comprise up to 1% of serum IgG. In this Phase I/II trial, patients with surgically resected pancreatic cancer will undergo a series of twelve intradermal injections with a vaccine composed of irradiated allogeneic pancreatic cancer cell lines (HAPa-1 and HAPa-2) that have been transduced with a recombinant Moloney murine leukemia virus (MoMLV)-based retroviral vector expressing the murine alpha (1,3) GT gene. Endpoints of the study include determination of dose-limiting toxicity (DLT), maximum tolerated dose (MTD), tumor and immunological responses.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Pancreatic Cancer|
|Intervention ICMJE||Biological: HyperAcute-Pancreatic Cancer Vaccine|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Marrow: hemoglobin greater than or equal to 10.0 gm/dL, absolute granulocyte count (AGC) greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, absolute lymphocyte count greater than or equal to 475/mm3.
Hepatic: serum total bilirubin less than or equal to 1.5 x ULN mg/dL, ALT (SGPT) and AST (SGOT) less than or equal to 2.5 x upper limit of normal (ULN).
Renal: serum creatinine (sCr) less than or equal to 2.0 x ULN, or creatinine clearance (Ccr) greater than or equal to 30 mL/min.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00255827|
|Other Study ID Numbers ICMJE||NLG0105|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Nicholas N. Vahanian, M.D., Chief Medical and Operations Officer, NewLink Genetics Corporation|
|Study Sponsor ICMJE||NewLink Genetics Corporation|
|Collaborators ICMJE||Not Provided|
|Information Provided By||NewLink Genetics Corporation|
|Verification Date||September 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP