Sipuleucel-T Manufacturing Demonstration Study, ver .01
Research type
Research Study
Full title
An Open-label Study of Sipuleucel-T in European Men with Metastatic, Castrate Resistant Prostate Cancer
IRAS ID
74793
Contact name
Thomas Powles
Sponsor organisation
Dendreon Corporation
Eudract number
2011-001192-39
Clinicaltrials.gov Identifier
Research summary
This research study will investigate an immunotherapy for advanced prostate cancer called sipuleucel-T (Provenge©). Provenge© is approved by the Food and Drug Administration in the USA for the treatment of advanced prostate cancer (metastatic disease that no longer responds to hormone therapy). A Manufacturing Authorization Application will soon be submitted to the EMA so that sipuleucel-T is available to many prostate cancer patients across Europe. The purpose of this study is to demonstrate that sipuleucel-T can be successfully manufactured at a European manufacturing facility. Another purpose is to collect and evaluate safety data. Sipuleucel-T is a type of treatment called an autologous cellular immunotherapy. It works differently from other kinds of prostate cancer treatment because it is designed to stimulate the patient??s own immune system to fight prostate cancer. Sipuleucel-T is made from the patient's own white blood cells (immune cells). These immune cells are taken from the patient using a process known as leucopheresis and are then subsequently sent to a manufacturing facility and mixed with a protein that stimulates/excites these immune cells to attack prostate cancer cells. The activated immune cells are then infused back into the patient. This process is completed 3 times for a total of 3 infusions. Studies done in the United States demonstrated that sipuleucel-T prolongs survival for patients with advanced prostate cancer by an average of over 4 months. Common side effects included chills, fatigue, fever, back pain, nausea, joint pain, and headache. These side effects usually occurred within 1 day of infusion, were mostly mild or moderate in severity, and usually resolve within 1 to 2 days. In this study all registered patients will be assigned to receive sipuleucel-T. There will not be a placebo or other comparator group. This study hopes to recruit 45 patients at four sites, one site in Austria, France, The Netherlands, and The United Kingdom. Each patient??s participation will last up to 95 days and the entire study will last approximately nine months. Eligible patients will include men, 18 years of age or older, who have prostate cancer that spread beyond the prostate (metastatic) and is no longer responding to the hormone therapy (castrate resistant). Patients must otherwise be in general good health with adequate blood, kidney, and liver function. Subjects who test positive for HIV, HTLV, Hepatitis B or Hepatitis C are not eligible, nor are subjects with brain metastasis or those who had more than 2 chemotherapy regimens. Patients must refrain from any prostate cancer medicines or other therapies and any other study drug within 28 days of registration. After patients provide informed consent they are screened for eligibility. If all inclusion and exclusion criteria are met the subject is registered and the first leucopheresis is performed followed 3 days later by the first infusion. One to two weeks later patients visit the clinic and are evaluated to make sure they are well enough for the next leucopheresis and infusion. This process is repeated for a total of 3 leucophereses and infusions. In order to demonstrate sipuleucel-T can be successfully manufactured at a European manufacturing facility, samples (1-2% of the cells) will be removed from each patient??s immune cell collections before and after they are mixed with the protein. Four immune system tests will be performed on these samples and the results of these tests will be summarized descriptively for comparison to results obtained during clinical studies in the US. These tests indicate if the immune cells are activated sufficiently by the protein. To measure safety, physical exams, vital signs, and laboratory samples will be measured and any side effects will be documented and summarized.
REC name
London - South East Research Ethics Committee
REC reference
12/LO/0068
Date of REC Opinion
23 May 2012
REC opinion
Further Information Favourable Opinion