Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00547144|
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : November 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Procedure: Dendritic Cell Immunotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547144
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Edgar G Engleman||Stanford University|
|Principal Investigator:||George Albert Fisher M.D. Ph.D.||Stanford University|