Feasibility Study on Stem Cells Sensitivity Assay (STELLA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Associazione Oncologia Traslazionale.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Associazione Oncologia Traslazionale
ClinicalTrials.gov Identifier:
NCT01483001
First received: October 27, 2011
Last updated: February 8, 2012
Last verified: November 2011
  Purpose

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 Intervention Phase
Lung Cancer
Colorectal Cancer
Breast Cancer
Drug: Cancer Stem Cells Sensitivity Assay
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: STELLA: a Feasibility Study on Stem Cells Sensitivity Assay

Resource links provided by NLM:


Further study details as provided by Associazione Oncologia Traslazionale:

Primary Outcome Measures:
  • Feasibility of the project [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of patients in which sensitivity assay is feasible


Secondary Outcome Measures:
  • Identification of LC, CRC and BC stem cells [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To identify drugs potentially effective for a specific patient


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Associazione Oncologia Traslazionale
ClinicalTrials.gov Identifier: NCT01483001     History of Changes
Other Study ID Numbers: LIVONCO 2011/001, 2011-003421-10
Study First Received: October 27, 2011
Last Updated: February 8, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Associazione Oncologia Traslazionale:
Cancer Stem Cells
Chemo-Sensitivity Assay
Cancer Treatment

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014