Gemcitabine and CT-011 for Resected Pancreatic Cancer
Condition: Pancreatic Neoplasms; Cancer of the Pancreas; Neoplasms Pancreatic; Pancreatic Cancer; Pancreas Cancer
MeSH terms: Neoplasms; Pancreatic Neoplasms
Intervention: CT-011; Gemcitabine
Intervention description: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.; 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adjuvant Therapy; Recombinant Monoclonal Antibody; Adenocarcinoma of the Pancreas; Vaccination; PD-1 Receptor; Pancreas Cancer; Pancreatic Cancer

Summary:

      Background:

        -  In 2009, 49,096 patients were diagnosed with pancreatic cancer. Pancreatic cancer
           carries a poor prognosis with an overall 5-year relative survival rate of 5.6%.

        -  Many doctors believe that individuals who have had surgery to remove pancreatic cancer
           should receive additional treatment, known as adjuvant therapy or adjuvant treatment, to
           prevent the cancer from returning. One chemotherapy drug that has been found to be
           effective in some patients with pancreatic cancer is called gemcitabine; it has been
           shown to improve patient survival by 6 months. Researchers are searching for new drugs
           or drug combinations to improve on these results.

        -  One of the leading causes for immune suppression in cancer patients was suggested to be
           associated with the elevated expression of programmed cell death ligand 1 (PD-L1) human
           B7 homolog 1 (B7-H1) at tumor-involved sites, either by the tumor itself or by
           surrounding cells like regulatory immune cells, resulting in the local suppression and
           apoptosis of tumor infiltrating effector lymphocytes.

        -  Some chemotherapy drugs kill cancer cells directly, but appear to prevent the immune
           system from helping in that fight. The experimental drug CT-011 is designed to help the
           immune system remain active to fight cancer cells. CT-011 has been tested in
           laboratories and studied for use with a number of other cancers, but it has not been
           given in combination with gemcitabine as a treatment for pancreatic cancer.

      Objective:

      - To test the safety and effectiveness of chemotherapy drugs gemcitabine and CT-011 as a
      follow-up treatment for pancreatic cancer that has been surgically removed.

      Eligibility:

      - Individuals at least 18 years of age who have had surgery to remove pancreatic cancer and
      have not had other types of follow-up treatments.

      Design:

        -  Participants will receive gemcitabine and CT-011 in 28-day cycles of treatment, and will
           be monitored throughout their treatment.

        -  Participants who do not have serious side effects and remain cancer-free may receive
           this drug combination every 28 days for a total of 6 cycles.

        -  Participants will have follow-up visits with additional blood tests every 2 months after
           stopping treatment for up to 2 years.
    

Eligibility criteria:

        -  Adult patients with histologic verification of carcinoma of the pancreas (T1-3, N0-1)
             who have undergone surgical resection within the past 4 - 12 weeks. Patients with R1
             resections are excluded.

          -  Must meet all laboratory safety criteria and not have active or history of autoimmune
             disease or conditions, be treated with immunosuppressive drugs, or require the use of
             systemic steroids. Primary intraoperative chemotherapy will be allowed.

          -  Pregnant or nursing women will be excluded. Subjects with active infection, HIV,
             Hepatitis B or C will be excluded.