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Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Jenna Rogers (650) 723-4467
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer

Recruiting Status:

Completed

Stanford Recruiting Status:

Completed

Condition(s):

Intervention(s):

  • Drug: Gemcitabine
  • Procedure: Dendritic Cell Immunotherapy
  • Procedure: Stereotactic Radiosurgery

Phase:

Phase 1

Eligibility

Ages Eligible for Study:

18 years to Any Age

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key 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.

Key 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.

Additional Study Details

Official Title:

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

Anticipated start date:

10/11/2005

Lead Sponsor:

Stanford University

Investigator(s):

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized

Masking:

Open

Control:

none

Assignment:

Single Group

Endpoints:

Safety/Efficacy

Primary Outcomes:

  • To evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells.
  • Phase II: To determine the overall response rate for this regimen as determined by radiographic criteria.
  • Phase I: To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with gemcitabine and stereotactic radiosurgery
  • To determine the time to tumor progression for this regimen.

Total Number to be Enrolled:

30

Total Number to be Enrolled at Stanford:

30

More Information

Trial Unique Id: SU-10112007-727

Secondary ID(s):

  • 95935
  • NCT00547144
  • PANC0003

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Jenna Rogers (650) 723-4467

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

4/22/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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