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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

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)


PRIMARY OBJECTIVES:

I. To determine the tolerability of delivering two standard doses of the PANVAC-F
(fowlpox)TM vaccine administered intratumorally in conjunction with subcutaneous injections
of PANVAC-V (vaccinia) followed by PANVAC-F (fowlpox) in conjunction with rH-GM-CSF vs.
subcutaneously injected PANVAC-V or PANVAC-F in conjunction with rH-GM-CSF in patients with
incurable pancreatic cancer based on local unresectability.

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 intratumoral recombinant fowlpox PANVAC vaccine
(PANVAC-F; falimarev).

Patients receive an intratumoral injection of PANVAC-F vaccine using endoscopic ultrasound
guidance. Patients also receive recombinant vaccinia PANVAC vaccine (PANVAC-V; inalimarev)
subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4. Patients then receive
PANVAC-F vaccine SC on days 15 and 29 and GM-CSF 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 PANVAC-F vaccine SC and GM-CSF SC (given on the day of and for 3 days after
each PANVAC-F vaccination) monthly in the absence of disease progression or unacceptable
toxicity. Beginning on day 71, patients with no irreversible or dose limiting toxicity ,
receive PANVAC-F vaccine SC (given on the day of and for 3 days after each PANVAC-F
vaccination) monthly in the absence of disease progression or unacceptable toxicity.

Patients will undergo biopsy periodically for correlative studies.

After completion of study treatment, patients are followed every 3 months.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed pancreatic
adenocarcinoma

- Patients may have locally advanced disease, not amenable to curative resection but
may not have clinically evaluable distant metastases or malignant ascites

- 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

- AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

- PT/PTT within normal institutional limits

- Amylase/lipase =< 1.5 X institutional upper limit of normal

- Creatinine =< 1.5 X institutional upper limit of normal

- Urine Protein =< grade 1 or 24-hour urine protein =< 1000 mg for patients with
proteinuria above 1+

- Urinalysis: No evidence of casts

- The effects of PANVAC-V (vaccinia) and/or PANVAC-F (fowlpox) on the developing human
fetus are unknown; for this reason, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for four months following the last vaccine dose;
should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately

- Patients may not have any other active illness (e.g., uncontrolled infection,
uncontrolled cardiac disease) that would preclude safe therapy

- Patients must sign a written informed consent document

Exclusion Criteria:

- 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
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events

- 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 GMCSF 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 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 because PANVAC-F (fowlpox) and/or
PANVAC-V (vaccinia) are agents with the potential for teratogenic or abortifacient
effects; because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with PANVAC-F (fowlpox) and/or PANVAC-V
(vaccinia) breast-feeding should not occur for at least 4 months following completion
of therapy with the recombinant vaccine

- 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;

- Individuals with active or a history of eczema or atopic dermatitis, or Darier's
disease; those with other acute, chronic or exfoliative skin conditions (e.g.,
burns, impetigo, varicella zoster, severe acne, contact dermatitis, psoriasis,
herpes or other open rashes or wounds) until the condition resolves

- Immunocompromised individuals (by disease or therapy) such as those with AIDS

- Concurrent malignancy (i.e., malignancy other than adenocarcinoma of the pancreas),
unless the subject has been curatively treated and disease free for >= 2 years,
except non-melanoma skin cancer or in-situ cervical cancer

- Splenectomy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD of falimarev defined as the dose level that 0/6 or 1/6 patients experience DLT and that at least 2/3 or 2/6 patients treated with the next higher dose have had DLT

Outcome Time Frame:

71 days

Safety Issue:

Yes

Principal Investigator

Elizabeth Poplin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03111

NCT ID:

NCT00669734

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell

Name

Location

Cancer Institute of New JerseyNew Brunswick, New Jersey  08901