Back to resultsAdjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GVAX pancreas vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer, pancreatic neoplasm, adenocarcinoma of the pancreas, stage IIl pancreatic cancer, adjuvant therapy, cancer vaccine, GVAX
Eligibility Criteria
Inclusion Criteria:
A. previously vaccinated subjects must receive Gvax vaccine previously
B. naïve and previously vaccinated subjects must meet the following criteria:
- have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
- received the last anti-cancer therapy at least 28 days ago.
- provide informed consent.
- have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)
- have adequate renal function (Serum creatinine ≤ 2 mg/dL).
- have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)
- agree to use adequate birth control, if of childbearing potential.
Exclusion criteria:
- radiographical evidence of pancreatic cancer disease recurrence
- documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
- uncontrolled medical problems
- systemic steroid therapy within 28 days before vaccine administration
- anticipated need for systemic steroid therapy within 28 days after vaccine administration
- evidence of active infections
- pregnant
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Previously vaccinated with GVAX pancreas vaccine
GVAX pancreas vaccine naive
Arm Description
Participants receive booster vaccination every 6 months, given intradermally.
Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Outcomes
Primary Outcome Measures
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
When calculating the incidences of adverse events, each adverse event (as defined by NCI CTCAE v3) will be counted only once for a given subject.
Secondary Outcome Measures
Overall Survival (OS)
The overall survival is defined as the time from the first vaccine boost until death. If a patient is lost to follow-up or the study is ended prior to death, the patient will be considered censored at their last recorded follow-up. The median survival estimates is based on the Kaplan Meier curve.
(Progression) Recurrence-free Survival (PFS)
PFS is defined as the time from the first vaccine until evidence of disease recurrence confirmed by first scan. If a patient withdraws from the study prior to being diagnosed with progressive disease, they will be censored at the date of their last follow-up visit. If an individual dies prior to being diagnosed with progressive disease, they will be considered to have progressed at the date of their last follow-up visit. The PFS will be summarized using Kaplan-Meier curves
Full Information
NCT ID
NCT00389610
First Posted
October 18, 2006
Last Updated
July 21, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
The Skip Viragh Foundation, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00389610
Brief Title
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2006 (Actual)
Primary Completion Date
October 11, 2021 (Actual)
Study Completion Date
December 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
The Skip Viragh Foundation, National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.
Detailed Description
Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene.
There will be two cohorts of research participants:
Participants previously vaccinated with GVAX pancreas vaccine. These participants will receive booster vaccinations as a continuation of care. Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity.
Participants who were not previously vaccinated with GVAX pancreas vaccine (vaccine naive). These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, pancreatic neoplasm, adenocarcinoma of the pancreas, stage IIl pancreatic cancer, adjuvant therapy, cancer vaccine, GVAX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Previously vaccinated with GVAX pancreas vaccine
Arm Type
Experimental
Arm Description
Participants receive booster vaccination every 6 months, given intradermally.
Arm Title
GVAX pancreas vaccine naive
Arm Type
Experimental
Arm Description
Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Intervention Type
Biological
Intervention Name(s)
GVAX pancreas vaccine
Other Intervention Name(s)
Two irradiated allogeneic pancreatic tumor cells transfected with the GM-CSF gene
Intervention Description
Given intradermally
Primary Outcome Measure Information:
Title
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
Description
When calculating the incidences of adverse events, each adverse event (as defined by NCI CTCAE v3) will be counted only once for a given subject.
Time Frame
14 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The overall survival is defined as the time from the first vaccine boost until death. If a patient is lost to follow-up or the study is ended prior to death, the patient will be considered censored at their last recorded follow-up. The median survival estimates is based on the Kaplan Meier curve.
Time Frame
16 years
Title
(Progression) Recurrence-free Survival (PFS)
Description
PFS is defined as the time from the first vaccine until evidence of disease recurrence confirmed by first scan. If a patient withdraws from the study prior to being diagnosed with progressive disease, they will be censored at the date of their last follow-up visit. If an individual dies prior to being diagnosed with progressive disease, they will be considered to have progressed at the date of their last follow-up visit. The PFS will be summarized using Kaplan-Meier curves
Time Frame
16 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A. previously vaccinated subjects must receive Gvax vaccine previously
B. naïve and previously vaccinated subjects must meet the following criteria:
have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
received the last anti-cancer therapy at least 28 days ago.
provide informed consent.
have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)
have adequate renal function (Serum creatinine ≤ 2 mg/dL).
have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)
agree to use adequate birth control, if of childbearing potential.
Exclusion criteria:
radiographical evidence of pancreatic cancer disease recurrence
documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
uncontrolled medical problems
systemic steroid therapy within 28 days before vaccine administration
anticipated need for systemic steroid therapy within 28 days after vaccine administration
evidence of active infections
pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A. Laheru, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
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