NCT00669734

Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery

Immunotherapy for Unresectable Pancreas Cancer: A Phase 1 Study of Intratumoral Recombinant Fowlpox PANVAC (PANVAC-F) Plus Subcutaneous Recombinant Vaccinia PANVAC (PANVAC-V), PANVAC-F and Recombinant Granulocyte-Macrophage Colony Stimulating Factor (rH-GM-CSF)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of vaccine therapy when given together with sargramostim in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy directly into the tumor together with sargramostim may cause a stronger immune response and kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the tolerability of delivering two standard doses of the PANVAC-F (fowlpox) (falimarev) vaccine administered intratumorally in conjunction with subcutaneous injections of PANVAC-V (vaccinia) (inalimarev) followed by PANVAC-F (fowlpox) in conjunction with rH-GM-CSF (sargramostim) versus (vs.) subcutaneously injected PANVAC-V or PANVAC-F in conjunction with rH-GM-CSF in patients with incurable pancreatic cancer based on local unresectability or with small volume metastases. SECONDARY OBJECTIVES: I. To assess the toxicity of the vaccine injections. II. To assess evidence of tumor response by imaging and tumor marker response. III. To assess gene transfer to pancreatic tissue. IV. To assess immunologic response to PANVACTM. OUTLINE: This is a dose-escalation study of falimarev. Patients receive falimarev vaccine intratumorally using endoscopic ultrasound guidance on day 1. Patients also receive inalimarev vaccine subcutaneously (SC) on day 1 and sargramostim SC on days 1-4. Patients then receive falimarev vaccine SC on days 15 and 29 and sargramostim SC on days 15-18 and 29-32 in the absence of unacceptable toxicity. Beginning on day 43, patients with stable or improving pancreatic cancer receive falimarev vaccine SC and sargramostim SC (given on the day of and for 3 days after each falimarev vaccination) monthly in the absence of disease progression or unacceptable toxicity. Beginning on day 71, patients with no irreversible or dose limiting toxicity, receive falimarev vaccine SC and sargramostim SC (given on the day of and for 3 days after each falimarev vaccination) monthly in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy periodically for correlative studies. After completion of study treatment, patients are followed every 3 months.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma
• Pancreatic Acinar Cell Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Stage III Pancreatic Cancer AJCC v6 and v7
• Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions

Type	Name	Description
BIOLOGICAL	Falimarev	Given intratumorally or SC
BIOLOGICAL	Inalimarev	Given SC
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Sargramostim	Given SC

Timeline

• Start date: 2010-02-01
• Primary completion: 2021-09-02
• Completion: 2026-04-23
• First posted: 2008-04-30
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States