Phase 2
Completed N=87
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery
Source: ClinicalTrials.gov NCT00727441 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0 — 3; 2; 4 Participants
Summary
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is more effective with or without cyclophosphamide in treating patients with pancreatic cancer.
PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given with or without cyclophosphamide in treating patients undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that can be removed by surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0 |
3; 2; 4 | — |
| PRIMARY Amount of T-regulatory Cells (Tregs) and CD4+ and CD8+ Effector T Cells, After Neoadjuvant GVAX Pancreatic Cancer Vaccination. |
— | — |
| PRIMARY Change in the Number and Function of Peripheral Mesothelin-specific CD8+ T Cells and CD4+, FoxP3+, and GITR+ Tregs |
— | — |
| SECONDARY Overall Survival |
34.2; 15.4; 16.5 | — |
| SECONDARY Disease Free Survival |
18.92; 8.54; 5.56 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas
- Stage I or II disease
- Surgically resectable disease (R0 or R1) by spiral CT scan
- No distant metastases
- A clear fat plane is present around the celiac and superior mesenteric arteries
- Patent superior mesenteric and portal veins
- Candidate for a pancreaticoduodenectomy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Serum creatinine ≤ 2 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN)
- Amylase ≤ 2 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Hyperbilirubinemia secondary to tumor-associated extrahepatic biliary obstruction allowed
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 4 weeks after the completion of study treatment
- No history of autoimmune disease, including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
- No uncontrolled medical problems
- No active infections
- No other cancer within the past 5 years except for superficial bladder cancer, nonmelanoma skin cancer, or low-grade prostate cancer not requiring therapy
PRIOR CONCURRENT THERAPY:
- More than 28 days since prior anticancer therapy
- No prior cancer immunotherapy, including the same pancreatic cancer vaccine used in this study
- More than 28 days since prior systemic steroid therapy or immunosuppressive therapy
- No systemic steroid therapy or immunosuppressive therapy during and within 28 days after vaccine administration
- No other concurrent immunotherapy, chemotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy for the treatment of pancreatic cancer
Data sourced from ClinicalTrials.gov (NCT00727441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.