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Phase 1
18 Years
Not Enrolling
Metastatic Pancreatic Carcinoma

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Trial Information

Inclusion Criteria:

- Pathologic diagnosis of pancreatic carcinoma

- Radiologic evidence of hepatic metastasis with at least one lesion > 2.0 cm that is
amenable to ultrasound or CT guided intra-tumoral DC injection

- Age > 18

- Life expectancy > 3 months

- Karnofsky Performance Status > 70%

- Patients must not have received any anti-neoplastic chemotherapy, immunotherapy or
radiotherapy for the four weeks preceding entry onto the study (six weeks for
nitrosoureas and mitomycin C).

- Adequate baseline hematopoietic function defined as WBC > 3000/mm3, hemoglobin >
9g/dl, and platelet count > 100,000/mm3.

- Adequate baseline organ function defined as creatinine < 2.0, total bilirubin < 2.0

- Patients taking warfarin are not eligible. Adequate coagulation function defined as
PT < 15, INR < 1.5 and PTT < 35.

- Ability to give informed consent

Exclusion Criteria:

- Previous anti-tumor vaccine therapy

- Prior hepatic irradiation

- Known brain metastases

- History of prior autoimmune diseases (e.g. SLE, rheumatoid arthritis, myasthenia

- Regular corticosteroid use within the past one year or any corticosteroid use in the
four weeks preceding study entry

- Evidence of HIV infection, AIDS, Hepatitis B or Hepatitis C infection

- Active bacterial, fungal or viral infection

- Pregnancy or lactation; women of childbearing potential and men must agree to use
effective contraception during the course of this clinical trial

- Uncontrolled or unstable medical conditions including angina, arrhythmias, bleeding,
or thromboembolic conditions,

- Any medical or psychiatric illness that might compromise the patients ability to
tolerate treatment

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:

To evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma.

Outcome Time Frame:

10 weeks

Safety Issue:


Principal Investigator

Mark M. Zalupski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universtiy of Michigan Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

UMCC 2005.135



Start Date:

October 2006

Completion Date:

June 2015

Related Keywords:

  • Metastatic Pancreatic Carcinoma
  • Carcinoma
  • Pancreatic Neoplasms



Universtiy of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109