Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery

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Brief Title

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery

Official Title

A Randomized Three-arm Neoadjuvant and Adjuvant Feasibility and Toxicity Study of a GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine Administered Either Alone or in Combination With Either a Single Intravenous Dose or Daily Metronomic Oral Doses of Cyclophosphamide for the Treatment of Patients With Surgically Resected Adenocarcinoma of the Pancreas

Brief Summary

      RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective
      immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as
      cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing. Giving vaccine therapy together with
      cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is
      more effective with or without cyclophosphamide in treating patients with pancreatic cancer.

      PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and
      to see how well it works when given with or without cyclophosphamide in treating patients
      undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that
      can be removed by surgery.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  To evaluate the safety and feasibility of a GVAX pancreatic cancer vaccine (GM-CSF
           gene-transfected allogeneic pancreatic cancer vaccine) when administered alone or in
           combination with a single intravenous dose or daily metronomic oral doses of
           cyclophosphamide as neoadjuvant and adjuvant treatment in patients with resectable stage
           I or II adenocarcinoma of the head, neck, or uncinate process of the pancreas.

        -  To assess the immune cell infiltrates, particularly T-regulatory cells (Tregs) and CD4+
           and CD8+ effector T cells, after neoadjuvant GVAX pancreatic cancer vaccination.

        -  To assess the changes in the number and function of peripheral mesothelin-specific CD8+
           T cells and CD4+, FoxP3+, and GITR+ Tregs after each GVAX pancreatic cancer vaccination
           when administered alone or in combination with a single dose or metronomic doses of
           cyclophosphamide.

      Secondary

        -  To estimate disease-free and overall survival of patients treated with these regimens.

        -  To estimate the effect of immune parameters on disease-free and overall survival of
           these patients.

      OUTLINE: Patients are randomized to 1 of 3 treatment arms.

        -  Arm A: Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 and
           undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery,
           patients receive an additional dose of the vaccine. Beginning approximately 1 month
           after vaccination, patients receive standard adjuvant chemoradiotherapy comprising
           gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning
           approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the
           vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 courses.

        -  Arm B: Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer
           vaccine ID on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately
           6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the
           vaccine on day 1. Beginning approximately 1 month after vaccination, patients receive
           standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or
           capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after
           the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on
           day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats
           every 28 days for 4 courses.

        -  Arm C: Patients receive GVAX pancreatic cancer vaccine ID on day 1 and low-dose oral
           cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on
           day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1
           and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Beginning
           approximately 1 month after vaccination, patients receive standard adjuvant
           chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy
           over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of
           chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral
           cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and
           cyclophosphamide repeats every 28 days for 4 courses.

      Patients undergo blood sample collection periodically for correlative laboratory studies,
      including immune cell analysis. Immune cell analysis includes monitoring the quantitative
      change of peripheral blood lymphocytes, including regulatory T cells (Tregs), and functional
      analysis of T-cell immune response. Tumor tissue samples collected at the time of surgery are
      analyzed for tumor antigens and infiltrating immune cells by immunohistochemistry and
      quantitative real-time PCR.

      After completion of study treatment, patients are followed periodically.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0

Secondary Outcome

 Overall Survival

Condition

Pancreatic Cancer

Intervention

GVAX pancreatic cancer vaccine

Study Arms / Comparison Groups

 Arm A
Description:  Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles.

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

Biological

Estimated Enrollment

87

Start Date

July 2, 2008

Completion Date

March 2020

Primary Completion Date

May 2015

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas

               -  Stage I or II disease

          -  Surgically resectable disease (R0 or R1) by spiral CT scan

               -  No distant metastases

               -  A clear fat plane is present around the celiac and superior mesenteric arteries

               -  Patent superior mesenteric and portal veins

          -  Candidate for a pancreaticoduodenectomy

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Hemoglobin ≥ 9 g/dL

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Serum creatinine ≤ 2 mg/dL

          -  AST and ALT ≤ 2 times upper limit of normal (ULN)

          -  Amylase ≤ 2 times ULN

          -  Alkaline phosphatase ≤ 5 times ULN

          -  Hyperbilirubinemia secondary to tumor-associated extrahepatic biliary obstruction
             allowed

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 4 weeks after the
             completion of study treatment

          -  No history of autoimmune disease, including systemic lupus erythematosus, sarcoidosis,
             rheumatoid arthritis, glomerulonephritis, or vasculitis

          -  No uncontrolled medical problems

          -  No active infections

          -  No other cancer within the past 5 years except for superficial bladder cancer,
             nonmelanoma skin cancer, or low-grade prostate cancer not requiring therapy

        PRIOR CONCURRENT THERAPY:

          -  More than 28 days since prior anticancer therapy

          -  No prior cancer immunotherapy, including the same pancreatic cancer vaccine used in
             this study

          -  More than 28 days since prior systemic steroid therapy or immunosuppressive therapy

          -  No systemic steroid therapy or immunosuppressive therapy during and within 28 days
             after vaccine administration

          -  No other concurrent immunotherapy, chemotherapy, radiotherapy, gene therapy, biologic
             therapy, or investigational therapy for the treatment of pancreatic cancer
      

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Daniel A. Laheru, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00727441

Organization ID

J0810

Secondary IDs

P30CA006973

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Daniel A. Laheru, MD, Principal Investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Verification Date

December 2019