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Adjuvant GVAX Vaccine Therapy in Patients With 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a vaccine called GVAX for patients with pancreatic cancer. The vaccine helps the immune system recognize and fight cancer cells. Some patients will receive additional doses over time.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
Secondary study objectives
Disease-free Survival (DFS)
Overall Survival (OS)
Side effects data
From 2022 Phase 2 trial • 56 Patients • NCT00389610100%
Erythema (vaccination site)
100%
Induration (vaccination site)
100%
Pruritus (vaccination site)
91%
Warmth (vaccination site)
82%
Tenderness (vaccination site)
82%
Flu-Like symptoms
36%
Pruritus
36%
Urticaria
36%
Myalgia
36%
Vaccine Flares (vaccination site)
36%
Chills
27%
Blisters
18%
Fatigue
18%
Anorexia
9%
Diarrhea
9%
Skin hyperpigmentation (vaccination site)
9%
Presyncope
9%
Arthralgia
9%
Weakness
9%
Nasal congestion
9%
Dry skin
9%
Lymphadenopathy
9%
Headache
9%
Fever
9%
Bruising (vaccination site)
9%
White blood cell count elevated
9%
Eosinophil count elevated
9%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Previously Vaccinated With GVAX Pancreas Vaccine
GVAX Pancreas Vaccine Naive
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
571 Previous Clinical Trials
33,275 Total Patients Enrolled
The Skip Viragh FoundationOTHER
3 Previous Clinical Trials
113 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,114 Total Patients Enrolled
Daniel A. Laheru, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
5 Previous Clinical Trials
544 Total Patients Enrolled