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Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma

Phase 1
18 Years
Open (Enrolling)
Locally Advanced Pancreatic Adenocarcinoma

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Trial Information

Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma

All study participants receive an initial 4 week course of intra-dermal vaccination with
telomerase vaccine (GV1001) and immune adjuvant, granulocyte macrophage colony-stimulating
factor (GM-CSF), along with a cycle of gemcitabine chemotherapy. This is followed by
concurrent radiation therapy and low-dose intravenous (IV) gemcitabine chemotherapy given
twice weekly followed by one additional dose of vaccine.

About 4 weeks (as late as 8 weeks) after chemotherapy and radiation treatment, participants
with disease that can be removed by surgery will proceed to surgery. After recovery,
immunochemotherapy will resume.

Participants with stable or responsive disease that is not able to be treated with surgery
will proceed to immunochemotherapy.

Immunochemotherapy will consist of 2 cycles of telomerase vaccine with GM-CSF along with
gemcitabine chemotherapy. Participants with disease that is not able to be treated with
surgery, or that has worsened following immunochemoradiotherapy phase of treatment may
continue on study with transition to immunochemotherapy phase of treatment. Tadalafil will
be administered orally on a daily basis from start of therapy (Day 1) through completion of
therapy with doses held only when required in the immediate perioperative period in patients
who proceed to surgery.

Inclusion Criteria:

Pancreatic adenocarcinoma proven by biopsy or cytology Locally advanced, unresectable
disease with absence of distant metastatic disease. The presence of non-regional
retroperitoneal or abdominal adenopathy is acceptable for inclusion.


Borderline resectable pancreatic adenocarcinoma (any of the following):

- Tumor abutment or encasement of a short segment of hepatic artery (without evidence
of tumor extension to the celiac artery) that is amenable to resection and

- Tumor abutment of the superior mesenteric artery involving 180 degrees or less of the
circumference of the artery and without encasement

- Impingement or narrowing of the superior mesenteric vein/portal vein or short-segment
(< 2 cm) occlusion of the superior mesenteric vein, portal vein, or their confluence
with a suitable option for vascular reconstruction

- Eastern Cooperative Oncology Group(ECOG)Performance Status 0 or 1

- Ability to give informed consent and comply with the protocol

- Women of childbearing potential must have a negative pregnancy test and must avoid
becoming pregnant while on treatment. Men must avoid fathering a child while on

- Patients with a history of psychiatric illness must be judged able to understand
fully the investigational nature of the study and the risks associated with the

Exclusion Criteria:

- Age < 18 years

- History of other malignancy in the past 2 years except carcinoma in situ of the
cervix or bladder, or non-melanomatous skin cancer

- Previous chemotherapy or radiation therapy for pancreatic cancer or previous
radiation therapy to the target field

- Clinically active autoimmune disease or active infection

- History of heart attack (within 90 days) or stroke (within 6 months), or presence of
hypertension requiring change in blood pressure medications in the last 4 weeks,
hypotension, uncontrolled arrhythmias, heart failure (New York Heart Association
(NYHA) Functional Classification ≥ Class 2 in last 6 months), unstable angina or
angina occurring during sexual activity.

- Use of "nitrates" or nitroglycerin.

- History of hereditary degenerative retinal disorders including retinitis pigmentosa.

- Chronic systemic corticosteroid use at supra-physiologic doses (prednisone > 10 mg a
day or equivalent)

- Use of recreational drugs called "poppers" like amyl nitrite and butyl nitrite.

- Laboratory values (performed within 14 days prior to enrollment) as follows:

- Neutrophil count < 1500 cells/µL

- Hemoglobin < 9 gm/dL (patients may be transfused to establish eligibility)

- Platelet count < 100,000 cells/µL

- Significant coagulopathy (INR > 1.5)

- Significant liver or renal dysfunction

- Other medical or psychiatric conditions that in the opinion of the Principal
Investigator would preclude safe participation in protocol.

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

Adverse events will be graded no less than weekly for the first 180 days. Post-treatment long-term follow-up will occur every 12 weeks beyond day 180 for 6 visits and then every 24 weeks thereafter until progressive disease, withdrawal from study or death. For this pilot study, adverse events and efficacy measures will be personally reviewed by the principal investigator. Both hematologic and non-hematologic toxicity will be anticipated. In conjunction with the IRB, stopping the trial will be among possible measures taken if undue toxicity or inadequate outcomes are observed.

Outcome Time Frame:

180 Days

Safety Issue:


Principal Investigator

Todd Crocenzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Providence Health & Services


United States: Food and Drug Administration

Study ID:

PHS 10-141B



Start Date:

January 2011

Completion Date:

April 2015

Related Keywords:

  • Locally Advanced Pancreatic Adenocarcinoma
  • pancreatic
  • cancer
  • adenocarcinoma
  • vaccine
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Providence Health & ServicesPortland, Oregon  97213