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

NCT00669734 | Active Not Recruiting Phase 1

• 6 other identifiers: NCI-2012-031110706027606P30CA072720U01CA132194UM1CA186716
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  71 days

Secondary Outcomes (3)

• Mean number of positive cells per high power field in the pancreas biopsy specimen

  Baseline

• T cell proliferation

  Up to 4 years

• Cytokine production

  Up to 4 years

Study Arms (1)

Treatment (vaccine therapy, sargramostim)

EXPERIMENTAL

Patients receive falimarev vaccine intratumorally using endoscopic ultrasound guidance on day 1. Patients also receive inalimarev vaccine 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.

Biological: Falimarev; Biological: Inalimarev; Other: Laboratory Biomarker Analysis; Biological: Sargramostim

Interventions

Falimarev BIOLOGICAL

Given intratumorally or SC

Also known as: fCEA-MUC-1-TRI, Fowlpox-CEA(D609)-MUC1(L93)-TRICOM Vaccine, Fowlpox-CEA-MUC-1-TRICOM, PANVAC-F, recombinant fowlpox-CEA-MUC-1-TRICOM vaccine, rFowlpox-CEA(D609)/MUC1(L93)/TRICOM Vaccine

Treatment (vaccine therapy, sargramostim)

Inalimarev BIOLOGICAL

Given SC

Also known as: PANVAC-V, recombinant vaccinia-CEA-MUC-1-TRICOM vaccine, rVaccinia-CEA(D609)/MUC1(L93)/TRICOM Vaccine, Vaccinia-CEA-MUC1-TRICOM Vaccine

Treatment (vaccine therapy, sargramostim)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vaccine therapy, sargramostim)

Sargramostim BIOLOGICAL

Given SC

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Treatment (vaccine therapy, sargramostim)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma
• Patients may have locally advanced disease, not amenable to curative resection; the site of pancreatic cancer must be amenable to endoscopic ultrasound (EUS) injection; patients with newly diagnosed metastatic disease of small volume may be included in the study at the investigator's discretion; such patients would be limited to those with:
• Liver involvement \< 10% of volume and no metastasis \> 2 cm, and/or
• Pulmonary involvement with no respiratory compromise and no metastasis \> 2cm and/or
• Peritoneal disease and no metastasis \> 2 cm and without ascites (as might be found on exploratory laparoscopy)
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 80%)
• Patients (in the opinion of the principal investigator) should be able to complete a full 3-month course of vaccination preferably with an anticipated survival of 6 months or longer
• Leukocytes \>= 3,000/mcL
• Hemoglobin \>= 8 gms/dL
• Absolute neutrophil count \>= 1,500/mcL
• Platelets \>= 100,000/mcL
• Total bilirubin =\< 1.5 X institutional upper limit of normal
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
• Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limits
• Amylase/lipase =\< 1.5 X institutional upper limit of normal

You may not qualify if:

• Patients may not have had radiotherapy to the pancreas
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving nor have received any other investigational agents within 28 days prior to registration
• Patients with known brain metastases should be excluded from this clinical trial
• History of allergic reactions or severe adverse reactions attributed to compounds of similar chemical or biologic composition to PANVAC-V (vaccinia) and/or PANVAC-F (fowlpox) which include but are not limited to the viral vectors vaccinia (small pox vaccination) and fowlpox, allergy to GM-CSF or to eggs which are used for the production of the vaccine
• Systemic corticosteroid therapy within 28 days of registration; topical steroids, steroid eye drops or inhaled steroids are contraindicated for at least 2 weeks before vaccinia vaccination and at least 4 weeks post vaccinia vaccination
• Uncontrolled intercurrent illness including, but not limited to active infection, symptomatic congestive heart failure or documented cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients with symptomatic cardiac disease or congestive heart failure who are not stable on current medications or have significant impairment of function such as class III New York Heart Association (NYHA), recent cardiac events including myocardial infarction or cerebrovascular accident within six months of entry, and/or unstable or uncontrolled arrhythmia or angina
• Active pancreatitis defined as clinically symptomatic hyperamylasemia and/or hyperlipasemia
• Pregnant women are excluded from this study; breast-feeding should not occur for at least 4 months following completion of therapy with the recombinant vaccine
• Human immunodeficiency virus (HIV)-positive patients and patients with hepatitis B and C are ineligible because of likely reduced immune competence which could affect the ability to respond to the vaccine
• Evidence of immunodeficiency or immune suppression; autoimmune diseases such as the following: autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren's syndrome, or scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
• Prior or concurrent extensive eczema or acute, chronic, or exfoliative skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster, varicella zoster, severe acne, or other open rashes or wounds)
• Unable to avoid close contact or household contact with the following high-risk individuals for 3 weeks after the PANVAC-V (vaccinia) vaccination:
• Children under the age of 3 year
• Pregnant or nursing women

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Interventions

sargramostim; Colony-Stimulating Factors

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Elizabeth A Poplin

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: April 30, 2008
• Study Start: February 1, 2010
• Primary Completion: September 2, 2021
• Study Completion (Estimated): April 21, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)