Cancer Vaccine + Chemotherapy + SBRT for Pancreatic Cancer

Palo Alto (17 mi)

Overseen byDaniel Laheru, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to estimate safety of GVAX Pancreas Vaccine (GVAX) with immune modulating doses of cyclophosphamide (Cy) followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery.

Eligibility Criteria

This trial is for pancreatic cancer patients who've had surgery to remove the tumor and are within 10 weeks post-operation. They should have a good performance status, no prior cancer treatments, and must agree to use birth control. Exclusions include serious heart, liver or other organ issues, metastatic disease, recent steroids or other therapies, HIV/hepatitis infections, pregnancy/lactation.

Inclusion Criteria

My pancreatic cancer was surgically removed.

I have not had chemotherapy, radiation, or biologic therapy for pancreatic cancer.

I have at least one titanium clip placed during surgery for treatment planning.

I can carry out all my usual activities without help.

Exclusion Criteria

I can start treatment within 10 weeks after my cancer surgery.

I do not have severe side effects from treatment as per NCI standards.

My cancer has spread to other parts of my body.

I have a history of HIV, hepatitis B, or hepatitis C.

I am currently taking steroids that affect my whole body.

Treatment Details

The study tests a pancreatic tumor cell vaccine (GVAX) with low-dose Cyclophosphamide followed by SBRT radiation and FOLFIRINOX chemotherapy in patients after surgical resection of pancreatic cancer. It aims to estimate the safety of this combination treatment.

3Treatment groups

Experimental Treatment

Group I: Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOXExperimental Treatment4 Interventions

The last 12 patients will receive Cy, GVAX, SBRT, and modified FOLFIRINOX.

Group II: Cohort 2: SBRT and modified FOLFIRINOXExperimental Treatment2 Interventions

The next 4 patients were treated with SBRT and modified FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If no patients are observed with grade 3-4 diarrhea, thrombocytopenia, or neutropenia, then the next cohort of patients will receive SBRT, modified FOLFIRINOX, and GVAX (with Cy).

Group III: Cohort 1: SBRT and FOLFIRINOXExperimental Treatment2 Interventions

The initial 3 patients were treated with SBRT and full dose FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If 2-3 patients are observed with uncontrolled grade 3-4 diarrhea, 2-3 patients are observed with grade 3-4 thrombocytopenia, or if 3 patients are observed with grade 3-4 neutropenia within the first 2 cycles of FOLFIRINOX administration (8 weeks) then the dose level will be deemed unacceptable.

FOLFIRINOX is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as FOLFIRINOX for: