Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

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Brief Title

Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

Official Title

A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Erbitux (Cetuximab) for the Treatment of Advanced Pancreatic Adenocarcinoma

Brief Summary

      RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune
      response to kill tumor 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. Monoclonal antibodies, such as cetuximab, can block tumor growth in
      different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop
      the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well vaccine therapy works when given together
      with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced
      pancreatic cancer.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  Determine the safety of pancreatic tumor vaccine, cyclophosphamide, and cetuximab in
           patients with metastatic or locally advanced adenocarcinoma of the pancreas.

      Secondary

        -  Determine the overall, progression-free, and event-free survival of patients treated
           with this regimen.

        -  Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate
           stem cell antigen [PSCA], mutated k-ras-specific T-cell responses) with clinical
           response in patients treated with this regimen.

        -  Correlate downstream targets of epidermal growth factor receptor (EGFR) signaling (e.g.,
           intratumor expression of Akt, Stat 3 and 5, mesothelin, mutated k-ras, and PSCA) with
           inhibition by cetuximab in patients treated with this regimen.

        -  Correlate inhibition of EGFR signaling (e.g., Stat 3 and 5) with improved specific
           mesothelin, PSCA, and mutated k-ras-specific T-cell responses in patients treated with
           this regimen.

      OUTLINE: This is an open-label study.

      Patients receive cyclophosphamide IV on day 0, sargramostim plasmid DNA pancreatic tumor
      vaccine intradermally on day 1, and cetuximab IV over 1-2 hours on days 1, 8, and 15.
      Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients undergo blood collection and tumor biopsies periodically during study for biomarker
      correlative studies.

      At the completion of study treatment, patients are followed at 3 weeks and then every 4 weeks
      for 16 weeks.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population


Condition

Pancreatic Cancer

Intervention

Cetuximab

Study Arms / Comparison Groups

 Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
Description:  

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

Drug

Estimated Enrollment

60

Start Date

December 2005

Completion Date

March 2009

Primary Completion Date

March 2009

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ductal adenocarcinoma of the pancreas

               -  Mixed adenocarcinoma tumors eligible provided the predominant invasive component
                  of the tumor is adenocarcinoma

          -  The following histologic diagnoses are not eligible:

               -  Adenosquamous

               -  Squamous cell

               -  Colloid

               -  Islet cell

               -  Serous or mucinous cystadenoma or cystadenocarcinoma

               -  Carcinoid

               -  Small or large cell carcinoma

               -  Intraductal oncocytic papillary neoplasms

               -  Osteoclast-like giant cell tumors

               -  Acinar cell carcinoma

               -  Pancreatoblastoma

               -  Solid pseudopapillary tumors

               -  Undifferentiated small cell carcinoma

               -  Nonepithelial tumors (sarcoma, gastrointestinal stromal tumor, lymphoma)

               -  Adenocarcinomas of the ampulla, distal bile duct, or duodenum

          -  Metastatic or locally advanced disease that is refractory to standard therapy OR for
             which patient refused standard therapy

          -  Measurable disease defined as ≥ 1 lesion unidimensionally measured as ≥ 20 mm by
             conventional techniques or ≥ 10 mm by spiral CT scan

               -  No nonmeasurable disease only including, but not limited to, the following:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural or pericardial effusion

                    -  Inflammatory breast disease

                    -  Lymphangitis cutis/pulmonis

                    -  Abdominal masses that are not confirmed and followed by imaging techniques

                    -  Cystic lesions

          -  No known active or untreated brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  WBC ≥ 3,500/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Platelet count ≥ 90,000/mm^3

          -  Creatinine ≤ 2.0 mg/dL

          -  Bilirubin ≤ 2 mg/dL

          -  ALT and AST ≤ 5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 5 times ULN

          -  No active infection

          -  No uncontrolled medical condition that would potentially increase the risk of
             toxicities or complications of study therapy

          -  No gastrointestinal tract disease resulting in an inability to take oral medication or
             a requirement for IV alimentation

          -  No active peptic ulcer disease

          -  Not pregnant or nursing

          -  Negative pregnancy test

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

          -  No other malignancy within the past 5 years except for nonmelanomatous skin cancer,
             superficial bladder cancer, or carcinoma in situ of the cervix

          -  HIV negative

          -  No active autoimmune disease or prior autoimmune disease requiring medical treatment
             with systemic immunosuppressants including any of the following:

               -  Inflammatory bowel disease

               -  Systemic vasculitis

               -  Scleroderma

               -  Psoriasis

               -  Multiple sclerosis

               -  Hemolytic anemia or immune thrombocytopenia

               -  Rheumatoid arthritis

               -  Systemic lupus erythematosus

               -  Sjögren's syndrome

               -  Sarcoidosis

               -  Asthma or chronic obstructive pulmonary disease that does not require systemic
                  corticosteroids or routine use of inhaled steroids allowed

          -  No known or suspected hypersensitivity to sargramostim (GM-CSF), cyclophosphamide,
             pentastarch, corn, or DMSO

          -  No prior severe infusion reaction (> grade 3) to a monoclonal antibody

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 1 month since prior adjuvant chemotherapy

          -  More than 4 weeks since prior surgery except for minor procedures (e.g., dental work,
             skin biopsy) and biliary stent placement

          -  No prior surgical procedures affecting absorption

          -  More than 4 weeks since prior radiotherapy

          -  More than 1 month since prior participation in an investigational new drug study

          -  No unresolved chronic toxicity (except alopecia) from prior anticancer therapy

          -  More than 28 days since prior systemic steroids

          -  No concurrent systemic steroids or immunosuppressive drugs

               -  Topical, inhaled, and intra-articular steroids allowed

          -  No other concurrent anticancer vaccine therapy

          -  No other concurrent chemotherapy, immunotherapy, radiotherapy, gene therapy, biologic
             therapy, or investigational therapy
      

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

NCT00305760

Organization ID

J0501

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

February 2020