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Trial record 50 of 2927 for:    Pancreatic Cancer AND pancreas

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00305760
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE March 21, 2006
First Posted Date  ICMJE March 22, 2006
Results First Submitted Date  ICMJE June 18, 2015
Results First Posted Date  ICMJE July 15, 2015
Last Update Posted Date July 15, 2015
Study Start Date  ICMJE December 2005
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
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 [ Time Frame: Continuous ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00305760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Cetuximab
    Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.
    Other Name: Erbitux
  • Biological: Pancreatic tumor vaccine
    Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.
    Other Names:
    • PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
    • GVAX
  • Drug: Cyclophosphamide
    Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.
    Other Name: Cytoxan
Study Arms  ICMJE Experimental: Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
Interventions:
  • Drug: Cetuximab
  • Biological: Pancreatic tumor vaccine
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2006)
60
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00305760
Other Study ID Numbers  ICMJE J0501
P30CA006973 ( U.S. NIH Grant/Contract )
BMS-CA225247
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Daniel A. Laheru, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP