Feasibility Study on Stem Cells Sensitivity Assay

NCT01483001 | Completed Phase 2

• 2 other identifiers: LIVONCO 2011/0012011-003421-10
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer; Colorectal Cancer; Breast Cancer

Keywords

Cancer Stem Cells; Chemo-Sensitivity Assay; Cancer Treatment

Outcome Measures

Primary Outcomes (1)

• Feasibility of the project

  Percentage of patients in which sensitivity assay is feasible

  6 Months

Secondary Outcomes (3)

• Identification of LC, CRC and BC stem cells

  6 Months

• Sensitivity of LC, CRC and BC stem cells to anti-tumor agents in vitro

  6 Months

• Identification of effective drugs for a specific patient

  6 months

Study Arms (1)

Sensitivity Assay

EXPERIMENTAL

Patients treated with a treatment chosen by sensitivity assay in vitro

Drug: Cancer Stem Cells Sensitivity Assay

Interventions

Cancer Stem Cells Sensitivity Assay DRUG

To test in vitro sensitivity of cancer stem cells to several antineoplastic drugs in order to personalize treatment

Also known as: Cancer stem cells in vitro chemo-sensitivity assay

Sensitivity Assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Associazione Oncologia Traslazionale: lead

Study Sites (1)

Department of Medical Oncology

Livorno, Livorno, 57100, Italy

Location

Related Publications (1)

• 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.

  PMID: 25955492 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• FEDERICO CAPPUZZO, ONCOLOGY

  A.O.T.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2013
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

IT (1)