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Targeted Delivery of OncoVEX GM-CSF by Endoscopic Ultrasound (EUS)-Guided Fine Needle Injection (FNI) in Patients With Irresectable Pancreatic Cancer: A Pilot Multinational Experiment on Safety and Proof of Concept

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Targeted Delivery of OncoVEX GM-CSF by Endoscopic Ultrasound (EUS)-Guided Fine Needle Injection (FNI) in Patients With Irresectable Pancreatic Cancer: A Pilot Multinational Experiment on Safety and Proof of Concept

The outcome for most patients with pancreatic cancer is very poor. Surgery offers the only
change for cure. Unfortunately, at the time of diagnosis, 80 to 90% of patients have
inoperable or metastatic disease. Chemotherapy (Gemcitabine) and chemoradiation therapy
offer only a small therapeutic effect and primarily affect pain and overall condition. Given
the poor prognosis of pancreatic cancer, many alternative strategies have been tested to
improve treatment results. A wide variety of gene and immunotherapies have been tested.

OncoVEX GM-CSF is a conditionally replication competent herpes simplex type-1 virus designed
for use in solid tumors. It has been specifically modified to replicate in tumors and to
provide a local source of the immune-stimulating cytokine, GM-CSF. It injected directly
into cancer tumors and is believed to destroy tumor cells by direct infection of the tumor
cells and an enhanced immune response due to the release of tumor antigens and GM-CSF

OncoVEX GM-CSF will be delivered directly to pancreatic tumors using EUS-FNI. A series of
three injections will be administered of 6 weeks. Patients will be hospitalized for the
first injection. Screening will occur within 3 weeks of the first injection and visits for
injections will occur at 0, 3 and 6 weeks. Spiral CT scans of chest and abdomen will be
done prior to each injection and again at 12 weeks (6 weeks after last injection)and also at
18 weeks if response has occurred. Assessments of pain, vital signs and laboratory
evaluations will occur at each visit. If appropriate patients may be offered up to three
additional injections.

Inclusion Criteria:

- cytological or histological proof of adenocarcinoma of the pancreas

- unresectable, locally advanced disease (isolated liver metastases are permitted)

- tumors of at least 1 cm diameter at screening

- measurable disease using RECIST criteria

- failure of either standard therapy, OR any one of the following:

- no alternative therapeutic of higher curative potential is available;

- investigator determination that patient could not tolerate alternative
therapeutic due to unacceptable toxicity; or,

- patient refusal to be treated with available alternative therapeutic

- age > 18 years

- life expectancy > 3 months

- adequate bone marrow function as indicated by:

- WBC ≥ 3.0 x 109/L

- platelets ≥ 100 x 109/L

- hemoglobin ≥ 8.5 gm/dL

- adequate liver function as indicated by:

- bilirubin < 1.5 x upper limit of normal (ULN)

- ALT or AST < 5 x ULN in case of presence of liver metastasis

- ALT or AST < 2.5 x ULN in case of absence of liver metastasis

- adequate renal function as indicated by a serum creatinine level < 1.5 x ULN.

- adequate hemostasis indicated by INR ≤ 1.5

- mentally, physically and geographically able to undergo treatment and follow-up

- provided written informed consent

- first patient in each cohort only: seropositive for HSV1

Exclusion Criteria:

- history of other malignancy within two years prior to screening, except for prostate
cancer (T1c, T2ab with definitive treatment, PSA < 1 ng/ml, and without ongoing
hormone suppression) or adequately treated in situ carcinoma of the cervix, basal
cell carcinoma, or squamous cell carcinoma of the skin

- cystic form of pancreatic cancer; microcystic disease may be eligible upon discussion
with Medical Monitor

- CTCAE v3 grade 2 or greater clinical pancreatitis within 8 weeks prior to dosing with

- other than metastases limited to the liver, imaging evidence of metastatic disease to
any other organ or tissue

- any serious concomitant systemic disorder that would compromise the safety of the
patient, at the discretion of the investigator

- evidence of compromised immune function including but not limited to:

- clinically significant absolute lymphocyte count < Lower Limit of Normal (LLN)

- known HIV, acute or chronic active hepatitis B, or hepatitis C infection;

- concurrently taking HIV antiviral medications (e.g. protease inhibitors, AZT,

- received IV, IM or SC human gamma globulin within 6 months prior to dosing with

- patients taking immunosuppressive agents (e.g. cyclosporine, tacrolimus, or oral or
systemic corticosteroids at a dose of >10mg/day of prednisone or equivalent).

- pregnancy, lactation or lack of effective contraception in women of child-bearing
potential (e.g., not post menopausal for > 2 years, or had tubal ligation); lack of
effective contraception in men if the partner is of child-bearing potential; women
must have been practicing an effective contraceptive method for at least three months
prior to entry in to the trial (hormonal contraception or intrauterine device in
conjunction with a barrier method); men must use a condom or be surgically sterilized

- patients with active bacterial or viral infections that require treatment with
systemic antibiotics or antiviral agents within 2 weeks prior to the first dose of
OncoVEXGM-CSF); (note: patients with active cold sores or other HSV1 infections must
wait until those lesions have crusted over before receiving OncoVEXGM-CSF)

- surgery requiring general or spinal anesthesia within four weeks prior to dosing with

- Treatment with an investigational agent within 4 weeks prior to the first dose of

- serum CA19.9 levels > 3000 U/mL at screening

- evidence of ascites on screening abdominal CT scan

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse event summaries of events, changes in vital signs, blood chemistry and hematology captured prior to and following treatment to end of study

Outcome Time Frame:

18 weeks

Safety Issue:


Principal Investigator

Neil N Senzer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mary Crowley Medical Research Center


United States: Food and Drug Administration

Study ID:

OncoVEX GM-CSF 005/04



Start Date:

November 2006

Completion Date:

March 2010

Related Keywords:

  • Pancreatic Cancer
  • Metastatic
  • Pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms



California Pacific Medical CenterSan Francisco, California  94115
UCI Medical CenterIrvine, California  92868
Mary Crowely Medical Research CenterDallas, Texas  75246