Cancer Vaccine for Pancreatic Cancer

Overseen By Carol A Judkins, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Systemic steroids

Disqualifiers: Autoimmune diseases, Uncontrolled medical problems, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months between vaccines

71 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the head, neck, tail or the uncinate process of the pancreas.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic steroid therapy within 28 days before or after the vaccine administration.

What data supports the effectiveness of the treatment PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine for pancreatic cancer?

Research on similar treatments, like the MUC1 DNA vaccine, shows that targeting specific proteins over-expressed in pancreatic cancer can trigger the immune system to fight the cancer. Additionally, studies on personalized mRNA vaccines have shown promise in delaying disease recurrence by activating specific immune cells in patients with pancreatic cancer. ^{1 2 3 4 5}

What makes the PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine treatment unique for pancreatic cancer?

This treatment is unique because it involves a DNA vaccine targeting specific proteins associated with pancreatic cancer, aiming to stimulate the body's immune system to attack cancer cells. Unlike traditional treatments, it uses genetic material to trigger an immune response, potentially offering a novel approach to combat pancreatic cancer. ^{1 3 4 5 6}

Research Team

Daniel Laheru, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

For Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766.

Has provided informed consent.

I received a specific pancreatic cancer vaccine 6-12 months ago.

Exclusion Criteria

I do not have any uncontrolled medical issues.

I have taken steroids in the last 28 days.

Is pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive boost vaccinations of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the GM-CSF gene, alone or in combination with cyclophosphamide

6 months between vaccines

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 years

Treatment Details

Interventions

• PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine

Trial Overview 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.

Participant Groups

Group I: Cohort 5 Experimental Treatment 1 Intervention

Cohort 5 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1766 study are eligible.

Group II: Cohort 4 Experimental Treatment 1 Intervention

Cohort 4 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J15237 study are eligible.

Group III: Cohort 3 Experimental Treatment 1 Intervention

Cohort 3 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1568 study are eligible.

Group IV: Cohort 2 Experimental Treatment 1 Intervention

Cohort 2 receives vaccine as well as a single dose of intravenous cyclophosphamide. Vaccine-naïve cohort. Closed to enrollment.

Group V: Cohort 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

The Skip Viragh Foundation

Collaborator

Trials

4

Recruited

170+

Findings from Research

The neoantigen-targeted vaccine PancVAX, developed using whole-exome and RNA sequencing, effectively activated T cells against pancreatic cancer in mice, leading to temporary tumor regression.

When combined with checkpoint modulators (anti-PD-1 and OX40 antibodies), PancVAX not only enhanced tumor regression but also promoted T cell memory, suggesting a potential for long-lasting immunity against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining STING-based neoantigen-targeted vaccine with checkpoint modulators enhances antitumor immunity in murine pancreatic cancer. Kinkead, HL., Hopkins, A., Lutz, E., et al.[2022]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Optimized construction of MUC1-VNTRn DNA vaccine and its anti-pancreatic cancer efficacy. [2020]

2. Greece pubmed.ncbi.nlm.nih.gov

MUC1 peptide vaccination in patients with advanced pancreas or biliary tract cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Induction of protective and therapeutic anti-pancreatic cancer immunity using a reconstructed MUC1 DNA vaccine. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Personalized mRNA Vaccine Immunogenic against PDAC. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Combining STING-based neoantigen-targeted vaccine with checkpoint modulators enhances antitumor immunity in murine pancreatic cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Implantation of a neoantigen-targeted hydrogel vaccine prevents recurrence of pancreatic adenocarcinoma after incomplete resection. [2022]