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GVAX pancreas vaccine for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Daniel A. Laheru, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A. previously vaccinated subjects must receive Gvax vaccine previously
have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 years
Awards & highlights

Study Summary

This trial is testing a new vaccine for pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
Secondary outcome measures
Disease-free Survival (DFS)
Overall Survival (OS)

Side effects data

From 2022 Phase 2 trial • 56 Patients • NCT00389610
100%
Induration (vaccination site)
100%
Erythema (vaccination site)
82%
Pruritus (vaccination site)
78%
Warmth (vaccination site)
76%
Tenderness (vaccination site)
51%
Flu-Like symptoms
36%
Eosinophil count elevated
29%
Vaccine Flares (vaccination site)
22%
Urticaria
22%
Fatigue
18%
Blisters
18%
Myalgia
16%
Anorexia
13%
Fever
13%
Chills
11%
Arthralgia
9%
Nasal congestion
9%
Malaise
9%
Headache
9%
Skin hyperpigmentation (vaccination site)
7%
Dry skin
7%
Nausea
7%
White blood cell count elevated
7%
Weakness
7%
Rash
7%
Lymphadenopathy
4%
Pruritus
4%
Bruising (vaccination site)
4%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
GVAX Pancreas Vaccine Naive
Previously Vaccinated With GVAX Pancreas Vaccine

Trial Design

2Treatment groups
Experimental Treatment
Group I: Previously Vaccinated With GVAX Pancreas VaccineExperimental Treatment1 Intervention
Participants receive booster vaccination every 6 months, given intradermally.
Group II: GVAX Pancreas Vaccine NaiveExperimental Treatment1 Intervention
Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GVAX pancreas vaccine
2006
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,824 Total Patients Enrolled
The Skip Viragh FoundationOTHER
3 Previous Clinical Trials
113 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,626 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this experiment?

"According to the official record on clinicaltrials.gov, this clinical trial is not presently enrolling patients. This trial was initially posted in September of 2006 and recently edited in September 2022 - although it is currently inactive, 699 other studies are actively recruiting participants at this time."

Answered by AI

What are the eligibility requirements for participating in this clinical research?

"Aspirants of this medical trial must have malignant neoplasm of the pancreas and be within 18 to 120 years old. 56 people are being sought out for enrollment."

Answered by AI

Does this clinical trial accept individuals above the age of 20?

"The requirements for participation in this medical trial dictate that the patient's age must be somewhere between 18 to 120 years. Additionally, there are 13 trials targeting under-18s and 696 studies focused on people aged 65 or over."

Answered by AI

What is the regulatory status of GVAX pancreas vaccine?

"Based on the current amount of information available, the safety of GVAX pancreas vaccine is rated a 2 by our team at Power. This trial is in its second phase and there are data that suggest it has some level of security but none to confirm efficacy."

Answered by AI
~3 spots leftby Mar 2025