GI-4000 With Adoptive Transfer in Pancreatic Cancer

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Brief Title

GI-4000 With Adoptive Transfer in Pancreatic Cancer

Official Title

Pilot Study Of Safety And Feasibility Of GI-4000, An Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With Adoptive Transfer And Chemoradiation in Locally Advanced Pancreatic Cancer

Brief Summary

      The purpose of this study is to determine if it is safe to add multiple immunotherapies to
      standard chemotherapy and radiation for treating pancreatic cancer tumors that cannot be
      completely removed by surgery.

        1. GI-4000 Vaccination:

           The first involves a "vaccine," which is an injection (shot) that teaches your immune
           system to attack foreign invaders. The vaccine we will use is called "GI-4000" - a
           vaccine composed of yeast that is made to carry the same proteins (called "mutated Ras
           proteins") found in some pancreatic cancer cells.

        2. Adoptive T-cell Transfer:

      The second type of immunotherapy in this study is called "adoptive T-cell transfer." This
      involves collecting a specific type of white blood cells from you (called "T-cells")and
      growing T-cells grown in a lab which may help the research participants' immune systems
      recover more quickly after chemotherapy, and possibly improved response to other
      immunotherapies.

      We hope that studying these agents together will teach us how to help the immune system fight
      pancreatic cancer.
    

Detailed Description

      This Phase I/Pilot study will assess the safety and feasibility of the GI-4000 series vaccine
      with or without adoptive T cell transfer in subjects with locally advanced pancreatic cancer
      undergoing chemotherapy, radiotherapy, and surgical resection. Subjects will be randomized to
      either ARM A (GI-4000vaccine) or ARM B (GI-4000 vaccine and activated T cell transfer). All
      subjects will undergo apheresis of mononuclear cells immediately before receiving four cycles
      of gemcitabine/oxaliplatin (GemOx) chemotherapy ("immune preservation phase"). After the
      completion of chemotherapy, the apheresis product will be reinfused, and the subjects will
      enter the "priming phase," in which two biweekly doses (dose #1 and #2) of the appropriate
      GI-4000 vaccine (the one that best matches the mutations found in the patient's tumor) and a
      single dose of the Prevnar pneumococcal conjugate vaccine will be administered. At this time,
      those subjects who have not developed distant metastatic disease by CT/MRI will undergo
      chemoradiation, with ARM B subjects receiving a second apheresis immediately prior to the
      initiation of the chemoradiation. The pheresed product will be activated and expanded ex vivo
      and reinfused after chemoradiation is completed. All subjects will receive two more biweekly
      boosts of the GI-4000 vaccine (doses #3 and #4) while undergoing restaging with CT/MRI
      ("boosting phase"). Those who have not developed metastatic disease will undergo surgical
      evaluation for tumor resection. Patients who undergo R0 or R1 resection will receive up to
      three more weekly doses of GI-4000 prior to the initiation of adjuvant gemcitabine, monthly
      doses of GI-4000 during the four cycles of gemcitabine chemotherapy, and monthly GI-4000
      doses thereafter. At the end of gemcitabine chemotherapy, apheresis will be performed for
      endpoint correlative studies. Those who are not candidates for surgery or whose tumors are
      not completely resected will continue to receive GI-4000 monthly booster vaccination.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

To evaluate the feasibility of incorporating GI-4000 vaccine and activated T-cell infusion into a regimen of chemotherapy, radiation, and surgical resection to treat locally advanced pancreatic cancer.


Condition

Pancreatic Cancer

Intervention

Screening

Study Arms / Comparison Groups

 All Subjects
Description:  Screening for Eligibility into Trial

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

0

Start Date

January 2008

Completion Date

October 2009

Primary Completion Date

October 2009

Eligibility Criteria

        Inclusion Criteria:

        Adult patients with untreated, locally advanced pancreatic adenocarcinoma that expresses a
        GI-4000 related k-ras oncoprotein.

          1. Histologically-confirmed pancreatic adenocarcinoma that expresses one of the
             GI-4000-related k-ras oncoproteins (G12V, G12C, G12D, Q61L, or Q61R)

          2. Locally advanced disease, (stages I-III, i.e no evidence of metastasis outside the
             pancreas and its regional lymph nodes). Preferred subjects for entry into the study
             are those with borderline resectable disease, as defined by:

               -  tumor that encases a short segment of the hepatic artery without extension to the
                  celiac axis and that is amenable to resection and reconstruction, OR

               -  tumor that abuts the superior mesenteric artery and that involves <180 degrees of
                  the circumference of the artery, OR

               -  short-segment occlusion of the superior mesenteric vein, portal vein, or their
                  confluence with a suitable option available for vascular reconstruction because
                  the veins are normal above and below the area of tumor involvement.

          3. Age >18 years

          4. ECOG performance status 0 or 1

          5. Normal organ and bone marrow function as defined by:

             Absolute neutrophil count > 1,500/μl Platelets > 100,000/μl AST(SGOT)/ALT(SGPT)< 2.5 X
             institutional upper limit of normal Bilirubin < 2.0 mg/dL unless due to bile duct
             blockage by tumor Creatinine < 1.5 x ULN

          6. A biliary stent 9F or biliary bypass before treatment, if tumor-related biliary
             obstruction is present

          7. The ability to sustain adequate hydration and nutrition (>1500 cal/d) by oral intake
             or access for supplemental enteral feeding (nasoenteral tube, feeding jejunostomy or
             PEG)

          8. Patients must have measurable disease by radiographic imaging, as defined by 1 lesion
             that can be accurately measured in at least one dimension (longest diameter to be
             recorded) as 20 mm with conventional techniques or 10 mm with spiral CT scanning.
             Marker elevation alone is insufficient for entry.

          9. Ability to understand and the willingness to sign a written informed consent
             documents.

         10. Adequate venous or catheter access and ability to tolerate apheresis.

        Exclusion Criteria:

          1. Tumor metastatic to peritoneum, liver or other organs

          2. Tumor that is clearly resectable for curative intent

          3. Prior chemotherapy, radiation therapy, targeted therapy, or immunotherapy for
             pancreatic cancer.

          4. Receipt of any other investigational agents within 30 days prior to screening

          5. Known HIV positive

          6. A major surgical procedure or significant traumatic injury within 28 days prior to
             anticipated initiation of chemotherapy, an anticipated major surgical procedure during
             the course of the study, or a minor surgical procedure (laparoscopy, fine needle
             aspiration, or core biopsy) within 7 days of anticipated initiation of chemotherapy.

          7. Serious non-healing wounds, ulcers, or bone fractures

          8. Pregnancy or ongoing breast-feeding, as chemotherapy may pose substantial risk to the
             fetus/infant.

          9. Patients whose treatment plan would require treating >50% of the liver to a dose
             greater than 30 Gy or treating > 50% of the total kidney volume to a dose greater than
             18 Gy

         10. Positive scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae.

         11. Active autoimmune disease requiring immunosuppressive therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter J. O'Dwyer, MD, , 



Administrative Informations


NCT ID

NCT00837135

Organization ID

806693

Secondary IDs

UPCC 03207

Responsible Party

Sponsor

Study Sponsor

University of Pennsylvania


Study Sponsor

Peter J. O'Dwyer, MD, Principal Investigator, University of Pennsylvania


Verification Date

August 2016