Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Microculture Kinetic (MiCK) Apoptosis Test Results With Drug Treatment Results in Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DiaTech Oncology
ClinicalTrials.gov Identifier:
NCT00901264
First received: May 12, 2009
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Correlation of the Microculture Kinetic (MiCK) Apoptosis Test Results With Drug Treatment Results in Cancer Patients

Resource links provided by NLM:


Further study details as provided by DiaTech Oncology:

Primary Outcome Measures:
  • To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients, with emphasis on patients failing primary treatment, patients with unknown primary tumors, and patients with tumors difficult to treat such as carcinoma of lung. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate the MiCK assay results with objective response rates, symptom response rates, time to progression and survival of cancer patients treated with chemotherapy. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: December 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with pathological diagnoses of cancer or leukemia
2
3.1.3 Patients for whom chemotherapy is planned.

Detailed Description:

Identification of those patients with cancer who will or will not respond to a specific chemotherapy is important for making decisions regarding chemotherapy regimens as well as alternative management approaches. A laboratory test that could help to determine the sensitivity of an individual patient's tumor cells to specific chemotherapeutic agents would be valuable in choosing the optimal chemotherapy regimen for that patient with an expectation of increasing the response rate to the therapy. Several types of in vitro assays that measure tumor cell survival following exposure to cytotoxic agents have been evaluated for their ability to predict chemotherapy outcomes. As a group, these assays are referred to as drug resistance assays. In a resistance assay, the surviving tumor cells can be detected directly by their exclusion or metabolism of specific dyes. Alternatively, since some of tumor cells are proliferating, their survival can be detected by measurement of DNA synthesis by radiolabeled precursor incorporation or demonstration of clonogenic potential by growth into colonies in semi-solid culture medium. In several clinical studies, these assays were useful in detecting drug resistance and in predicting a poor prognosis for cancer patients. However, these resistance assays cannot detect sensitivity of an individual patient's tumor cells to a specific drug. Therefore, new methods determining drug-sensitivity of the tumor cells of an individual patient and, thus, capable of both predicting a positive treatment outcome and guiding chemotherapy, would be of significant value.

Recently, an automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells has been developed1-4. Apoptosis is a distinct mode of cell death which occurs under physiological conditions and yet can be induced in malignant cells by chemical and physical factors including antitumor drugs5-7. During the last decade, it has been recognized that chemotherapeutic agents exert their antitumor activity by triggering apoptosis in susceptible tumor cells8-17. This implies that the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells. Unlike "resistance" assays that measure a fraction of cells surviving drug exposure, the MiCK assay measures a fraction of tumor cells killed by a chemotherapeutic agent via mechanism of apoptosis. Therefore the MiCK assay determines drug sensitivity, rather than resistance. Recently the MiCK assay has been shown to predict complete remission rate and survival in acute myeloid leukemia patients better than clinical criteria did18-20. In a limited study, the MiCK assay has been used to direct chemotherapy of the leukemia patients 21.

The MiCK assay has also been used to study drug-induced apoptosis in solid tumors, including neuroblastoma and colon adenocarcinoma cell lines22-23. More recent data accumulated by DiaTech has demonstrated that the MiCK assay can detect drug induced apoptosis in primary cultures of tumor cells isolated from patients with ovarian carcinoma, gastric carcinoma, metastatic breast cancer and high grade soft tissue sarcoma. The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer Patients for whom chemotherapy is planned.

Criteria

Inclusion Criteria:

  • 3.1.1 Patients with pathological diagnoses of cancer or leukemia
  • 3.1.2 Patients must have tumor which is accessible for biopsy and agree to undergo tumor biopsy, or drainage of malignant effusion, and the specimen must be submitted for MiCK assay.
  • 3.1.3 Patients for whom chemotherapy is planned.

Exclusion Criteria:

  • 3.2.1 Patients with symptomatic/uncontrolled parenchymal brain or meningeal metastasis and tumors not accessible for biopsy.
  • 3.2.2 Patients who are pregnant. Pregnancy. During the course of the study, all patients of childbearing potential should be instructed to contact the treating physician if they suspect they might have conceived a child; for females, a missing or late menstrual period should be reported to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient must not receive chemotherapy in this study and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study. If a male patient is suspected of having fathered a child while on the study, the pregnant female partner must be notified and counseled regarding the risk to the fetus. Pregnancy during the course of this study will be reported to the Principal Investigator as a serious adverse event. Women of child bearing potential are defined to include any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhea for more than 12 consecutive months); these includes also females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.
  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: NCT00901264

Locations
United States, California
Wilshire Oncology Medical Group, Inc
La Verne, California, United States, 91750
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Tennessee
DiaTech Oncology
Brentwood, Tennessee, United States, 37027
Cumberland Medical Center
Crossville, Tennessee, United States, 38555
Middle Tennessee Medical Center
Murfreesboro, Tennessee, United States, 37219
Baptist Hospital
Nashville, Tennessee, United States, 37203
Nashville Oncology Associates
Nashville, Tennessee, United States, 37203
St. Thomas Research Institute, LLC
Nashville, Tennessee, United States, 37203
Tennessee Breast Specialists
Nashville, Tennessee, United States, 37203
Tennessee Toracic Surgical Specialists
Nashville, Tennessee, United States, 37205
Canada, Quebec
DiaTech Oncology
Montreal, Quebec, Canada, H2X 3P9
Sponsors and Collaborators
DiaTech Oncology
Investigators
Study Director: Cary Presant, MD DiaTech Oncology
Principal Investigator: Dirk Davidson, MD Cumberland Medical Center
Principal Investigator: Karl Rogers, MD Nashville Oncology Associates
Principal Investigator: Swapnil P. Rajurkar, MD Wilshire Oncology Medical Group, Inc.
Principal Investigator: Laura Lawson, MD Tennessee Breast Specialists
Principal Investigator: L. James Wudel Jr., MD Tennessee Thoracic Surgical Specialists
Principal Investigator: Raymond F Bluth, MD Baptist Hospital Nashville
Principal Investigator: Peter F Jelsma, MD St. Thomas Research Institute, LLC
Principal Investigator: Richard D Michaelson, MD Middle Tennessee Medical Center
Principal Investigator: Jorge E Marcet, MD Tampa Gerneral Hospital
  More Information

No publications provided

Responsible Party: DiaTech Oncology
ClinicalTrials.gov Identifier: NCT00901264     History of Changes
Other Study ID Numbers: Master Study DiaTech Oncology
Study First Received: May 12, 2009
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by DiaTech Oncology:
Chemosensitivity, chemotherapy, all cancers, personalized chemotherapy, personalized cancer treatment
Cancer Patients for whom chemotherapy is planned.

ClinicalTrials.gov processed this record on November 25, 2014