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Cancer Vaccine

Cancer Vaccine for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Daniel 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

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).

Must not have

Has any uncontrolled medical problems.

Has any evidence of active infections.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up total of 13 years with 6 months between vaccines.

Awards & highlights

No Placebo-Only Group

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled medical issues.

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I currently have an active infection.

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My pancreatic cancer has come back, as shown on scans.

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I have a history of autoimmune diseases like lupus or rheumatoid arthritis.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 9Eligibility criteria met