For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available at www.clinicaltrials.gov.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
CLINICAL TRIAL- NCT02151448
ADC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
Official Title- A Phase ½ Trial Evaluating aDC1 Vaccines Combined With Tumor-Selective Chemokine Modulation as Adjuvant Therapy After Surgical Resection of Peritoneal Surface Malignancies
Listing on www.clinicaltrials.gov
Sponsor: Pawel Kalinski M.D. in collaboration with National Cancer Institute
Location: Hillman Cancer Center Pittsburgh, Pennsylvania
Principal Investigator: David L Bartlett M.D. University of Pittsburgh
Contact: David L. Bartlett MD 412 692 2852 firstname.lastname@example.org or Natlaie Streeter BA MSN RN 412 235 1276 email@example.com
Number of Participants: 168 participants- Start Date July 2014 Estimated completion December 2017
Purpose: “This trial is to determine the safest dose of a triple combination (chemokine modulatory regimen or CKM) of celecoxib, interferon alpha (IFN), and rinatolimod that can be given with a DC vaccine as treatment of peritoneal surface malignancies ater standard of care surgery.
- 18 years of age candidate for surgical reconstruction. Patient has confirmed malignancy of the peritoneum. Patients may have had extensive prior treatments. An ECOG performance status of 0.1 or 2
- Patient must be able to swallow pills.
- Patient must have normal organ function as defined below
- Platelets greater than 75000, hemoglobin greater than 9/0 hematocrit greater than 27
- use of steroids must be removed at least 3 weeks’ prior administration of vaccination
- History of transplant or autoimmune disease
- Patients who are pregnant or nursing
- Patients with myocardial infarction or ischemia within 3 months prior to
- Allergic reactions to or hypersensitivity to Celcoxib or NSAIDs
How the Research Study is Designed to Work:
The trial will evaluate the safety and effectiveness of triple combinations of celecoxib, interferon and rintatolimod that can be given with a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery.
The patient must be a surgical candidate with peritoneal mesothelioma. Once this is determined patient will undergo resection at University of Pittsburgh with Dr. Bartlett. While in the operating room, the surgeon will remove a piece of tumor and send it off to the lab. After recovering from surgery patient will have leukaphereses, a lab procedure in which the white blood cells are separated from the blood, it will then be transported to the lab where the tumor is. These two components will be made to form a vaccine. Once recovered from surgery, the treatment of the vaccine will be delivered to the patient. One will be given intradermally (one of the routes of administration used for vaccinations, layer of skin under the epidermis) and one will be given into the lymph nodes. Four weeks after surgery patient will receive intravenous Intraferon which will be given every day, Rintatolimod will be given on Wednesday and Friday of that same week. Celecoxib will be given every day as well during that week. The patient must stay in the Pittsburgh area for these weekly treatments. The goal is to get this regime every 4 weeks. The quality of tumor extracted from the operating room will define how large of a vaccine can be made. If there is residual vaccine it will be up to the patient and team whether administration is continued.
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