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

Sponsor:

Information provided by (Responsible Party):

Associazione Oncologia Traslazionale

Study Description

Brief Summary:

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

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Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer Lung cancer

MedlinePlus related topics: Allergy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Feasibility of the project [ Time Frame: 6 Months ]
Percentage of patients in which sensitivity assay is feasible

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically/cytologically confirmed diagnosis of metastatic LC, CRC or BC
Availability of tumor tissue suitable for CSCs extraction
Performance status of 100% according to Karnofsky score
Failure of conventional therapies or no therapy of proven efficacy
Adequate hematological, renal and liver functions
No concomitant comorbidity potentially interfering with the study
Informed consent form signature.

Exclusion Criteria:

Performance status <100% according to Karnofsky score
Patient suitable for standard therapies
Important comorbidity interfering with the study
Significant alteration of liver, hematological or renal function(s)
No informed consent form signature

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Italy
Department of Medical Oncology
Livorno, Italy, 57100

Sponsors and Collaborators

Associazione Oncologia Traslazionale

Investigators


Principal Investigator:	FEDERICO CAPPUZZO, ONCOLOGY	A.O.T.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

D'Arcangelo M, Todaro M, Salvini J, Benfante A, Colorito ML, D'Incecco A, Landi L, Apuzzo T, Rossi E, Sani S, Stassi G, Cappuzzo F. Cancer Stem Cells Sensitivity Assay (STELLA) in Patients with Advanced Lung and Colorectal Cancer: A Feasibility Study. PLoS One. 2015 May 8;10(5):e0125037. doi: 10.1371/journal.pone.0125037. eCollection 2015.


Responsible Party:	Associazione Oncologia Traslazionale
ClinicalTrials.gov Identifier:	NCT01483001 History of Changes
Other Study ID Numbers:	LIVONCO 2011/001 2011-003421-10 ( EudraCT Number )
First Posted:	December 1, 2011 Key Record Dates
Last Update Posted:	January 14, 2015
Last Verified:	January 2015

Keywords provided by Associazione Oncologia Traslazionale:


Cancer Stem Cells Chemo-Sensitivity Assay Cancer Treatment

Additional relevant MeSH terms:


Colorectal Neoplasms Hypersensitivity Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Immune System Diseases

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