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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: MTD of falimarev, defined as the dose level that 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) and that at least 2/3 or 2/6 patients treated with the next higher dose have had DLT [ Time Frame: 71 days ]

The descriptions and grading scales found in the Cancer Therapy Evaluation Program (CTEP) Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for adverse events (AE) reporting.


Original Primary Outcome: Maximum tolerated dose of intratumoral recombinant fowlpox PANVAC vaccine (PANVAC-F; falimarev)

Current Secondary Outcome:

  • Cytokine production [ Time Frame: Up to 4 years ]
    Analyzed by comparing pretreatment responses to post treatment responses for absolute differences and/or percent increase.
  • Mean number of positive cells per high power field in the pancreas biopsy specimen [ Time Frame: Baseline ]
    Compared between groups using the Fisher exact test.
  • T cell proliferation [ Time Frame: Up to 4 years ]
    Analyzed by comparing pretreatment responses to post treatment responses for absolute differences and/or percent increase.


Original Secondary Outcome: T-cell proliferation and cytokine production before and after treatment.

Information By: National Cancer Institute (NCI)

Dates:
Date Received: April 29, 2008
Date Started: February 2010
Date Completion:
Last Updated: January 31, 2017
Last Verified: December 2016