Feasibility Study on Stem Cells Sensitivity Assay

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associazione Oncologia Traslazionale

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