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
3 other identifiers
interventional
2
1 country
1
Brief Summary
To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pancreatic-cancer
Started Oct 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 18, 2007
CompletedFirst Posted
Study publicly available on registry
October 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedNovember 8, 2012
August 1, 2012
2.5 years
October 18, 2007
November 6, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
o 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.
Study Arms (1)
Gemcitabine
EXPERIMENTALInterventions
1000 mg/m2 intravenoulsy once a week according to protocol schedule
The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)
Eligibility Criteria
You may qualify if:
- \. 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.
- \. 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.
- \. 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).
- \. 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.
You may not qualify if:
- \. 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.
- \. 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.
- \. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edgar G Engleman
Stanford University
- PRINCIPAL INVESTIGATOR
George Albert Fisher M.D. Ph.D.
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
October 18, 2007
First Posted
October 22, 2007
Study Start
October 1, 2005
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
November 8, 2012
Record last verified: 2012-08