Feasibility Study on Stem Cells Sensitivity Assay (STELLA)
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|ClinicalTrials.gov Identifier: NCT01483001|
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : January 14, 2015
Lung Cancer (LC), colorectal cancer (CRC) and breast cancer (BC) are the major killers in oncology, accounting for about 40% of cancer deaths. Although progresses have been made in the last few years, unfortunately no patient with metastatic disease can obtain a definitive cure.
A recent hypothesis is that cancer is driven by a small subpopulation of cells called "cancer stem cells" (CSCs) or "tumor initiating cells" with an unlimited proliferative potential and the ability to reproduce the original human tumor in experimental animal models. These cells are thought to be responsible for the development of the tumor and represent the only cell population able to sustain tumor growth and progression.
Therefore, CSCs represent the elective target for new targeted therapies, endowed with high and selective toxicity towards the tumor but harmless towards normal cells.
Current technologies allow us to isolate and expand in vitro the CSCs from tumor specimens, testing their sensitivity to different anticancer drugs in a short period of time.
Therefore, there is the potential opportunity to identify LC, CRC and BC CSCs.This is a prospective study assessing feasibility of CSCS isolation in LC, CRC and BC.
Patients with a previously performed diagnosis of LC, colon cancer or breast cancer with no further standard therapy options, with a Karnofsky performance status of 100% and with tumor tissue available will be considered eligible for the study. Tumor tissue will be collected before study entry, i.e tissue obtained during a diagnostic or therapeutical procedure, like surgery or biopsies with other purposes than the protocol. In vitro tumor sensitivity to chemotherapy drugs will be tested on tumor cell cultures per each patient.
Drugs and their combination will be considered effective and if they kill ≥ 60% of tumor stem cells in vitro test. By using cancer spheres the investigators will also generate orthotopic xenograft models that recapitulate the parental tumor behaviour, including the aggressive features and the invasiveness potential. Orthotopic injection technique will be assessed in 5 weeks-old NOD/SCID mice
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Colorectal Cancer Breast Cancer||Drug: Cancer Stem Cells Sensitivity Assay||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||STELLA: a Feasibility Study on Stem Cells Sensitivity Assay|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2013|
Experimental: Sensitivity Assay
Patients treated with a treatment chosen by sensitivity assay in vitro
Drug: Cancer Stem Cells Sensitivity Assay
To test in vitro sensitivity of cancer stem cells to several antineoplastic drugs in order to personalize treatment
Other Name: Cancer stem cells in vitro chemo-sensitivity assay
- Feasibility of the project [ Time Frame: 6 Months ]Percentage of patients in which sensitivity assay is feasible
- Identification of LC, CRC and BC stem cells [ Time Frame: 6 Months ]Identification of breast, colo-rectal and lung cancer stem cells by flow cytometric analysis or immunofluorescence
- Sensitivity of LC, CRC and BC stem cells to anti-tumor agents in vitro [ Time Frame: 6 Months ]In vitro tumor sensitivity to chemotherapy drugs will be tested on tumor cell cultures per each patient.
- Identification of effective drugs for a specific patient [ Time Frame: 6 months ]To identify drugs potentially effective for a specific patient
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): NCT01483001
|Department of Medical Oncology|
|Livorno, Italy, 57100|
|Principal Investigator:||FEDERICO CAPPUZZO, ONCOLOGY||A.O.T.|