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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 a history of surgically resected and pathologically proved AJCC stage I or stage II adenocarcinoma of the head, neck, or uncinate of the pancreas.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total of 13 years with 6 months between vaccines.
Awards & highlights
No Placebo-Only Group

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 below
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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.
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I've never had pancreatic cancer vaccine/immunotherapy, had Whipple surgery within 18 months, and finished my adjuvant therapy.
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My blood counts are within the required range.
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I received a specific pancreatic cancer vaccine 6-12 months ago.
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It has been over 28 days since my last cancer treatment.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total of 13 years with 6 months between vaccines.
This trial's timeline: 3 weeks for screening, Varies for treatment, and total of 13 years with 6 months between vaccines. for reporting.

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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,844 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

Frequently Asked Questions

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

Does the FDA sanction this medication?

"Power's assessment rates the safety of this trial as a 2. While there is some evidence backing its safety, Phase 2 trials have not yet established efficacy."

Answered by AI

What are the usual conditions that doctors prescribe this medication for?

"This treatment can help patients with multiple sclerosis, mixed-cell type lymphoma, and leukemia, myelocytic, acute."

Answered by AI

How many individuals are being recruited for this clinical trial?

"Yes. The most recent update on clinicaltrials.gov was on March 3rd, 2022 and it indicates that this study is still looking for 72 volunteers at a single site."

Answered by AI

Are people still being signed up for this clinical trial?

"Yes, this is an ongoing study that has currently posted on clinicaltrials.gov seeking 72 participants from 1 site. The trial was first published on 4/20/2010 and the most recent update was 3/3/2022."

Answered by AI
~2 spots leftby Aug 2024