Feasibility Study on Stem Cells Sensitivity Assay (STELLA)

Study Description

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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

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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

Arms and Interventions

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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

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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
2. 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.
3. Identification of effective drugs for a specific patient [ Time Frame: 6 months ]
   To identify drugs potentially effective for a specific patient

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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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

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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
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