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Cancer Vaccine
Cancer Vaccine for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Lei Zheng, 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
Has adequate hematologic function (Hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, Platelets ≥ 100,000 K/ mm3).
Has adequate renal function (Serum creatinine ≤ 2 mg/dL).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total of 13 years with 6 months between vaccines.
Awards & highlights
Study Summary
This trial tests a new cancer vaccine given with or without a low dose of chemotherapy. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for individuals who've had surgery to remove stage I or II pancreatic cancer and have completed any additional therapies at least 28 days ago. They should be in good physical condition (ECOG status of 0 or 1) with proper kidney, blood, and liver function. Women must agree to use birth control if they can have children. People with recurrent pancreatic cancer, uncontrolled health issues, recent steroid therapy, pregnancy, active infections, autoimmune diseases or other cancers within the last five years cannot join.Check my eligibility
What is being tested?
The study tests boost vaccinations using a genetically modified pancreatic tumor cell vaccine either alone or combined with cyclophosphamide (a chemotherapy drug). The goal is to see if these vaccines are safe and workable as long-term treatments for patients who've had certain types of pancreas surgeries.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site like pain and swelling, flu-like symptoms such as fever and chills, fatigue from immune system activation by the vaccine. Cyclophosphamide might cause nausea, hair loss, mouth sores or increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood counts are within the required range.
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My kidney function is good (creatinine ≤ 2 mg/dL).
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My liver is functioning well according to recent tests.
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I had surgery for early-stage pancreatic cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ total of 13 years with 6 months between vaccines.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total of 13 years with 6 months between vaccines.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free overall survival.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment1 Intervention
Cohort 5 receives vaccine as well as a single dose of intravenous cyclophosphamide.
Only participants from J1766 study are eligible.
Group II: Cohort 4Experimental Treatment1 Intervention
Cohort 4 receives vaccine as well as a single dose of intravenous cyclophosphamide.
Only participants from J15237 study are eligible.
Group III: Cohort 3Experimental Treatment1 Intervention
Cohort 3 receives vaccine as well as a single dose of intravenous cyclophosphamide.
Only participants from J1568 study are eligible.
Group IV: Cohort 2Experimental Treatment1 Intervention
Cohort 2 receives vaccine as well as a single dose of intravenous cyclophosphamide. Vaccine-naïve cohort.
Closed to enrollment.
Group V: Cohort 1Experimental Treatment1 Intervention
Arm A: Vaccine only. Arm B receives vaccine as well as a single dose of intravenous cyclophosphamide. Arm C: In addition to Vaccine Cohort 3 receives a daily dose of metronomic cyclophosphamide orally.
Only patients from the J0810 study are eligible.
Closed to enrollment.
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,028 Total Patients Enrolled
The Skip Viragh FoundationOTHER
3 Previous Clinical Trials
98 Total Patients Enrolled
Lei Zheng, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
71 Total Patients Enrolled
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