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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier:
NCT00547144
First received: October 18, 2007
Last updated: November 6, 2012
Last verified: August 2012

October 18, 2007
November 6, 2012
October 2005
April 2008   (final data collection date for primary 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. [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Phase II: To determine the overall response rate for this regimen as determined by radiographic criteria. [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • To determine the time to tumor progression for this regimen. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00547144 on ClinicalTrials.gov Archive Site
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Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer
A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: Gemcitabine
    1000 mg/m2 intravenoulsy once a week according to protocol schedule
    Other Name: Gemzar
  • Procedure: Dendritic Cell Immunotherapy
    The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)
    Other Names:
    • DC Therapy
    • Dendritic Cell Therapy
Experimental: Gemcitabine
Interventions:
  • Drug: Gemcitabine
  • Procedure: Dendritic Cell Immunotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
April 2008
April 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547144
PANC0003, 95935, 1454
Yes
George Albert Fisher, Stanford University
George Albert Fisher
Not Provided
Principal Investigator: Edgar G Engleman Stanford University
Principal Investigator: George Albert Fisher M.D. Ph.D. Stanford University
Stanford University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP