Pancreatic Cancer
Conditions
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, pancreatic neoplasm, adenocarcinoma of the pancreas, stage IIl pancreatic cancer, adjuvant therapy, cancer vaccine, GVAX
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: 1. 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. 2. 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.
Interventions
BIOLOGICALGVAX pancreas vaccine
Given intradermally
Sponsors
The Skip Viragh Foundation
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity | 14 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 16 years | OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. |
| Disease-free Survival (DFS) | 16 years | DFS is defined as the time from the first dose until evidence of disease recurrence or progression confirmed by first scan. DFS will be censored at the date of the last scan for subjects without documentation of disease recurrence or progression at the time of analysis. Estimation based on the Kaplan-Meier curve. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Previously Vaccinated With GVAX Pancreas Vaccine Participants receive booster vaccination every 6 months, given intradermally | 11 |
| GVAX Pancreas Vaccine Naive Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally. | 45 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Disease Progression | 0 | 19 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Previously Vaccinated With GVAX Pancreas Vaccine | GVAX Pancreas Vaccine Naive | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 16 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 29 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 44 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 42 Participants | 51 Participants |
| Sex: Female, Male Female | 4 Participants | 19 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 26 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 11 | 42 / 45 |
| other Total, other adverse events | 11 / 11 | 45 / 45 |
| serious Total, serious adverse events | 1 / 11 | 0 / 45 |
Outcome results
Primary
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.
Time frame: 14 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Previously Vaccinated With GVAX Pancreas Vaccine | Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity | 1 Participants |
| GVAX Pancreas Vaccine Naive | Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity | 5 Participants |
Secondary
Disease-free Survival (DFS)
DFS is defined as the time from the first dose until evidence of disease recurrence or progression confirmed by first scan. DFS will be censored at the date of the last scan for subjects without documentation of disease recurrence or progression at the time of analysis. Estimation based on the Kaplan-Meier curve.
Time frame: 16 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Previously Vaccinated With GVAX Pancreas Vaccine | Disease-free Survival (DFS) | 109.5 Months |
| GVAX Pancreas Vaccine Naive | Disease-free Survival (DFS) | 13.7 Months |
Secondary
Overall Survival (OS)
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: 16 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Previously Vaccinated With GVAX Pancreas Vaccine | Overall Survival (OS) | 80.5 Months |
| GVAX Pancreas Vaccine Naive | Overall Survival (OS) | 30.7 Months |