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A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer


Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed
adenocarcinoma of the pancreas. The site of the primary lesion should be confirmed
endoscopically, radiologically, or surgically to be in the pancreas.

2. Patients must be deemed unresectable due to involvement of critical vasculature,
adjacent organ invasion, presence of metastasis, or other medical condition making
surgical resection unfavorable.

3. Patients must have a primary or metastatic lesion measurable in at least one dimension
by RECIST criteria within 4 weeks prior to entry of study 4. More than 4 weeks must have
elapsed from the time of major surgery or completion of the last dose of chemotherapy,
radiation therapy, investigational therapy and patients must adequately recover from these
effects.

5. Life expectancy of >3 months. 6. Karnofsky performance status >70%. 7. Patients must
have normal organ and marrow functions as defined below: absolute neutrophil count
>1,500/mm3 platelets >70,000/mm3 total bilirubin <1.5 mg/dL AST(SGOT)/ALT(SGPT) <2.5 X
institutional upper limit of normal creatinine within normal institutional limits OR
creatinine clearance >60mL/min/1.73 m2 for patients with creatinine levels above
institutional normal.

albumin > 2.8 mg/dL 8. Patients must have adequate clotting function (platelet > 70k;
INR<1.4; PTT<60).

9. Age >18 years. 10. The effects of DCs 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) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.

11. No history of autoimmune diseases. 12. Ability to understand the study protocol and a
willingness to sign a written informed consent document.

Exclusion Criteria:1. Patients receiving anticoagulation therapy. 2. Patients who have
received prior gemcitabine or radiation therapy to the pancreatic bed 3. Patients
receiving any other investigational agents. 4. Patients with known brain metastases will
be excluded because of their poor prognosis and because they often develop progressive
neurological dysfunction that would confound the evaluation of neurological and other
adverse effects.

5. Uncontrolled concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situation that would limit compliance with study
requirements.

6. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

o evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells.

Outcome Time Frame:

unknown

Safety Issue:

No

Principal Investigator

Edgar G Engleman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

PANC0003

NCT ID:

NCT00547144

Start Date:

October 2005

Completion Date:

April 2008

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317