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Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

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: NCT00389610
Recruitment Status : Active, not recruiting
First Posted : October 19, 2006
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Viragh Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE October 18, 2006
First Posted Date  ICMJE October 19, 2006
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE September 2006
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Safety as measured by local and systemic toxicities [ Time Frame: Until progression ]
Patients continue to receive vaccines until disease progression
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00389610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Overall survival [ Time Frame: time of first vaccine until death ]
  • Recurrence-free survival [ Time Frame: the time from the first vaccine until evidence of disease recurrence ]
  • Immune response, in terms of mesothelin, prostate stem cell antigen, and mutated k-ras-specific T-cell responses, as measured by biopsy, histological analysis, and in vitro assays at baseline and at 4 weeks post vaccination [ Time Frame: will be computed for each patient at two time points around each vaccine boost: pre-vaccination and four weeks post vaccination ]
  • Antitumor immunity, in terms of shared tumor-specific antigens and k-ras-specific antitumor immune responses, as measured at baseline and at 4 weeks post vaccination [ Time Frame: . Autologous lymphocytes will be obtained from peripheral blood before each vaccination, and at four weeks following each vaccinations. ]
  • Correlation of immune response with clinical response [ Time Frame: Serum will be obtained from each research participant on days 0 and 3 of treatment. ]
  • Correlation of sargramostim (GM-CSF) serum levels with longevity of an allogeneic vaccine as measured by pharmacokinetic (PK) studies at baseline and at day 3 [ Time Frame: Serum will be obtained from each research participant on days 0 and 3 of treatment. Pharmacokinetic parameters will be estimated, when possible, using standard compartmental models. ]
  • Correlation of PK parameters with clinical outcomes [ Time Frame: The relationship between pharmacokinetic parameters and clinical outcomes will be assessed using logistic regression for binary outcomes (e.g. toxicity) and Cox proportional hazards models for time to event outcomes (e.g. OS, PFS). ]
  • Psychosocial profiles (demographics, quality of life [QOL], hope, social support, decision control) and symptom profile (pain, anorexia, fatigue, mood state) as measured by City of Hope QOL, Cancer Patient/Survivor version [ Time Frame: day 0 and day 28 of the each vaccination ]
  • Psychosocial profiles of long-term cancer survivors as measured by the Herth Hope Index at baseline and day 28 of the first vaccination and each semiannual vaccination [ Time Frame: baseline and day 28 of the first vaccination and each semiannual vaccination ]
  • Psychosocial profiles of long-term cancer survivors as measured by Trust Scale at baseline and day 28 of the first vaccination and each semiannual vaccination [ Time Frame: baseline and day 28 of the first vaccination and each semiannual vaccination ]
  • Psychosocial profiles of long-term cancer survivors as measured by Pancreatic Cancer Survivor Survey at baseline [ Time Frame: baseline of the first vaccination ]
  • Symptom profile (pain, anorexia, fatigue, mood state) by EORTC QLQ-C30 v3 at baseline and day 28 of the first vaccination and each semiannual vaccination [ Time Frame: baseline and day 28 of the first vaccination and each semiannual vaccination ]
  • Symptom profile (pain, anorexia, fatigue, mood state) by Symptom Distress Scale at baseline and day 28 of the first vaccination and each semiannual vaccination [ Time Frame: baseline and day 28 of the first vaccination and each semiannual vaccination ]
  • Identification of markers of clinical response [ Time Frame: The CA 19-9 levels will be followed to evaluate whether large and persistent changes might correlate with either in vitro immune responses or with time to clinical recurrence. ]
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 in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Official Title  ICMJE A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
Brief Summary

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of pancreatic cancer.

PURPOSE: This phase II trial is studying the side effects and how well vaccine therapy works in treating patients with pancreatic cancer that has been removed by surgery.

Detailed Description

OBJECTIVES:

Primary

  • Determine the safety of primary and boost vaccinations with lethally irradiated allogeneic pancreatic tumor cells transfected with sargramostim (GM-CSF) gene vaccine in patients with surgically resected adenocarcinoma of the head, neck, or uncinate of the pancreas.

Secondary

  • Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate stem cell antigen, and mutated k-ras-specific T-cell responses) with clinical response in patients treated with this regimen.
  • Determine the efficacy, in terms of overall and recurrence-free survival, of this regimen in these patients.
  • Correlate serum GM-CSF levels with longevity of an allogeneic vaccine after semi-annual boosting in these patients.
  • Determine the psychosocial (e.g., demographics, quality of life, hope, trust, social support, decision control, and advanced directives) and symptom (e.g., pain, anorexia, fatigue, and mood state) profiles in these patients and explore changes over time.

OUTLINE: This is a open-label study. Patients are stratified according to prior vaccination with allogeneic sargramostim (GM-CSF)-secreting pancreatic tumor cell vaccine (yes [stratum I] vs no [stratum II]).

  • Stratum I: Patients receive booster vaccination comprising allogeneic GM-CSF plasmid DNA pancreatic tumor cell vaccine subcutaneously (SC). Treatment repeats every 6 months in the absence of disease progression or unacceptable toxicity.
  • Stratum II: Patients receive priming vaccinations SC once a month for 3 months and then receive booster vaccinations as in stratum I.

Patients complete self-reported psychosocial (including quality of life, hope, and trust) and symptom (including pain, fatigue, anorexia, and mood) questionnaires at day 0 and day 28.

After completion of study treatment, patients are followed at day 28 and then annually for 15 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Biological: allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine
Given subcutaneously
Other Name: Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo
Study Arms  ICMJE
  • Experimental: Stratum I
    Patients receive booster vaccination comprised of an allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine, given subcutaneously (SC). Treatment repeats every 6 months.
    Intervention: Biological: allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine
  • Experimental: Stratum II
    Patients receive priming vaccinations comprised of allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine, given SC once a month for 3 months and then receive booster vaccinations as in stratum I.
    Intervention: Biological: allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
56
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of adenocarcinoma of the head, neck, tail, or uncinate of the pancreas meeting the following criteria:

    • Stage I-III disease
    • Prior surgical resection required
  • No radiographic evidence of disease recurrence

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.0 mg/dL (unless due to known Gilbert's syndrome)
  • AST, ALT, and amylase ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other uncontrolled illness
  • No active, ongoing infection
  • No history of autoimmune disease (e.g., systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 28 days since prior anticancer therapy (e.g., adjuvant chemoradiotherapy)
  • At least 28 days since prior systemic steroid therapy
  • At least 6 months since last vaccination with sargramostim (GM-CSF) plasmid DNA pancreatic tumor cell vaccine (cell lines Panc 10.05 and Panc 6.03) while enrolled on SKCCC-J9617 or SKCCC-J9988
  • No concurrent systemic steroid therapy during and for ≥ 28 days after vaccination
  • No concurrent radiation therapy
  • No other concurrent immunotherapy, biologic therapy, or gene therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (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 NCT00389610
Other Study ID Numbers  ICMJE J0619
P30CA006973 ( U.S. NIH Grant/Contract )
NA_00002731 ( Other Grant/Funding Number: JHM IRB )
JHOC-SKCCC-J0619
JHOC-00002731
JHOC-GT0604170201
JHOC-0607-799
CDR0000508892 ( Other Identifier: other )
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)
  • Viragh Foundation
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 September 2019

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