This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
Objectives:
1)To determine the impact of the varying does and schedules of doctetaxel on CEA-specific T cell immune responses using the ELISPOT assay
2) To determin the recommended dose and schedule for further study as defined by the best immune response with acceptable toxicity
3) To document any objective antitumor response that occurs
4) To determine the impact of treatment on the quantity of circulating CEA cells using quantative real time PCR as an intermediate endpoint
Medical Relevance:
Patients with advanced metastatic CEA-bearing cancers of the colon or lung have very limited treatment options and those available have not been proven to improve overall survival. This is a population for which new therapies are needed. Cancer immunotherapy and target therapy has made significant advances in the last few years but when given alone they may succeed in stabilization of disease but have limited potential for causing major responses in patients with heavy tumor burden. Exploration of the combination of immunotherapy with chemotherapy is a logical next step to take in furthering the development of new treatment options for this group of patients.
Expected Outcome:
The endpoints of this trial are:
1) Tumor response measured according to standard RECIST criteria
2) Imune response will be measured by ELISPOT
3) The number of patients experiencing and toxicities will be recorded and the toxicity rate will be determined.
4) The number of circulating cancer cells will be determined by RT-PCR.
It is expected that this trial will identify the best combination of terms of disease response, immune response, and toxicity to bring forward into a large Phase II trial.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
Antitumor ResponseBiological AssayCellsColon CarcinomaComputer Retrieval of Information on Scientific Projects DatabaseDevelopmentDiseaseDoseEnd PointFundingGrantImmune responseImmunotherapyInstitutionLungMeasuresMedicalNumbersOutcomePatientsPhase II Clinical TrialsPolymerase Chain ReactionPopulationRateResearchResearch PersonnelResourcesReverse Transcriptase Polymerase Chain ReactionScheduleSourceStandards of Weights and MeasuresT-LymphocyteTimeToxic effectTumor BurdenUnited States National Institutes of Healthcancer immunotherapychemotherapycirculating cancer celldocetaxelenzyme linked immunospot assayexperienceimprovedresponsetumor
No Sub Projects information available for 5M01RR020359-03 6298
Publications
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