Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis - Full Text View

Sponsored by:	DiaTech Oncology
Information provided by:	DiaTech Oncology
ClinicalTrials.gov Identifier:	NCT00243685

Purpose

DiaTech is a private company performing patient specific cancer chemosensitivity testing for patients and physicians. DiaTech Oncology is doing this clinical study to see if an experimental new technology called the microculture kinetic (MiCK) assay will predict treatment outcome and can help to direct the chemotherapy of cancer subjects. This study is focused on subjects diagnosed with breast, ovarian, lung, and colon malignancies and low-grade lymphomas.

Study Objectives:

To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients.
To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients.

Condition	Intervention	Phase
Breast Neoplasms Lung Neoplasms Ovarian Neoplasms Sarcoma, Soft Tissue	Other: Laboratory Assay Other: Mick Assay	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Caregiver), Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Drug Testing Sensitivity of Solid Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lung Cancer Ovarian Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by DiaTech Oncology:

Primary Outcome Measures:

To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients [ Time Frame: After chemotherapy ] [ Designated as safety issue: No ]
To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients [ Time Frame: after chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
II and III: Experimental Not applicable	Other: Laboratory Assay Chemotherapy Other: Mick Assay Chemotherapy doctor determined from results

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with pathological diagnoses of breast, lung, and ovarian adenocarcinomas and soft tissue sarcoma.
Patients with de novo malignancies and no previous chemotherapy
Patients with advanced refractory malignancies who received no more than 2 standard chemotherapy treatment protocols.
Patients of any age group.
Patients must have tumor which is accessible and agree to undergo biopsies, or drainage of effusions.
Patients for whom chemotherapy is a treatment option.

Exclusion Criteria:

Patients with symptomatic/uncontrolled parenchymal brain metastasis and non-accessible tumors.
Patients with meningeal metastasis.
Patients for whom chemotherapy is not clinically indicated.
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 study medication 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 drugs, 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 childbearing 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); this also includes females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243685

Locations

United States, Tennessee
Nashville Breast Center	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Francie Hubbard, RN, CRC 615-284-8229 ext 118
Principal Investigator: Pat Whitworth, MD
Nashville Oncology Associates	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Karl Rogers, MD 615-284-2310 noaonc@bellsouth.net
Contact: Connie Rogers, NP 615 284 2310 noaonc@bellsouth.net
Principal Investigator: Karl Rogers, MD
United States, Texas
Cancer Care Centers of South Texas	Recruiting
San Antonio, Texas, United States, 78229
Contact: Glenda Chambers, RN 210-595-5683
Principal Investigator: Alexander Zweibach, MD, PhD

Sponsors and Collaborators

DiaTech Oncology

Investigators

Principal Investigator:	Cary Presant, MD	Medical Director DiaTech Oncology
Principal Investigator:	Pat Whitworth, MD	Director, Nashville Breast Center, PC
Principal Investigator:	Alexander Zweibach, MD, PhD	Cancer Care Centers of South Texas
Principal Investigator:	Karl Rogers, MD	Nashville Oncology Associates

More Information

Additional Information:

More Information on MiCK Assay Technology This link exits the ClinicalTrials.gov site

Publications:

REFERENCES 1. Kravtsov V. A novel microculture kinetic assay (MiCK assay) for malignant cell growth and chemosensitivity. Eur J Cancer,30A,10,1564-70,1994 2. Kravtsov V, Fabian I. Automated monitoring of apoptosis in suspension cell cultures. Lab Invest,74,2,557-70,1996. 3. Kravtsov V, Greer J,Whitlock J, Koury M Use of the microculture kinetic (MiCK) assay of apoptosis to determine chemosensitivities of leukemias. Blood,92,968-980,1998 4. Kravtsov V, Daniel T, Koury M. Comparative analysis of several methodological approaches to the in vitro studies of cell apoptosis. Am J Pathology,155,1327-1339, 1999. 5. Clarke PG, Clarke S. Historic apoptosis. Nature,378,230,1995 6. Majno G, Joris I. Apoptosis, oncosis, and necrosis. An overview of cell death. Am J Pathol,146,1,3-15,1995 7. Kuprianou N,English HF, Davidson NE, Isaacs JT. Programmed cell death during regression of the MCF-7 human breast cancer following estrogen ablation. Cancer Res,51,162-6,1991 8. Warri AM, Huovinen LR, Laine AM, Martikainen PM, Harkonen PL. Apoptosis in toremifene-induced growth inhibition of human breast cancer cells in vivo and in vitro. J Natl Canc Inst,85,17,1993 9. Krajewski S, Blomqvist C, Franssila K, Krajewska M, et al. Reduced expression of proapoptotic gene Bax is associated with poor response rates to combination chemotherapy and shorter survival in women with metastatic breast adenocarcinoma. Cancer Res,55,4471-78,1995 10. Bergman PJ, Kiefer JA, Price JE, Ley PB, Wynn P, Bucana C, O'Brian CA, McConkey DJ. Acquisition of apoptosis resistance with chemoresistance and metastatic potential in human breast cancer: roles of bcl-2 and bcl-x (L). Proc Annu Meet Am Assoc Cancer Res, 37, A115,1996. 11. Wu J. Apoptosis and angiogenesis: two promising tumor markers in breast cancer. Anticancer Res,16,2233-40,1996 12. Williams GT. Programmed cell death: apoptosis and oncogenesis. Cell,65,1097-98,1991. 13. Marx J. Cell death studies yield cancer clues.Science,259,760-1,1993. 14. Kerr JFR., Winterfold CM, Harmon BV. Apoptosis. Its significance in cancer and cancer therapy. Cancer, 73,8,2013-26,1994. 15. Hannun Y. Apoptosis and the dilemma of cancer chemotherapy. Bllod,89,6,1845-53,1997 16. Wyllie AH, Kerr JFR, Currie AR : Cell death : The significance of apoptosis. Int Rev Cytol 68 : 251, 1980. 17. Gorczyca W, Bruno S, Darzynkiewics RJ, Gong J, Darzynkiewics Z : DNA strand breaks occurring during apoptosis : Their early in situ detection by the terminal deoxynucleotidyl transferase and nick translation assays and prevention by serine protease inhibitors. Int J Oncol 1 : 639, 1992. 18. Kravtsov V, J.P. Greer, Y. Shyr, D.J.Haselton, J.A. Whitlock, S. Goodman, R.S. Stein, M.J. Koury Prediction of survival and responses to chemotherapy in acute myelogeneous leukemia (AML) by the microculture kinetic (MiCK) assay of apoptosis. Blood,92:677a, 1998 19. Kravtsov V, J. Greer, Y. Shyr, J. Whitlock, T., T.McCurley, Goodman, R. Stein, S.Krantz, M. Koury Prediction of survival in acute non-lymphocytic leukemia (AML). Blood,98:214b, 2001 20. Kravtsov V, J. Greer, Y. Shyr, J. Means, J. Whitlock, T., T.McCurley, Goodman, R. Stein, S.Krantz, M. Koury Prospective study evaluating ability of the MiCK assay for apoptosis to predict complete remission and survival in de novo acute myeloid leukemia (manuscript is being submitted for publication). 21. Kravtsov V, V.Priego, J.Reilly, H.Sethi, J.Cooke,W.Smith,M.Koury Chemotherapy of myeloid leukemia directed by a microculture kinetic assay for apoptosis. Blood, 96:3129, 2000. 22. Zang J, Kravtsov V, Amarnath V, Picklo M, Graham D, Montine T. (2000) Enhancement of dopaminergic neurotoxicity by the mercapturate of dopamine: relevance to Parkinson's disease. J Neurochem , 74,970-978. 23. Schultz R, M.Rothenberg, M.Koury, W.Hankins, V.Kravtsov. Sequence dependence using combination of Alimta (pemetrexed disodium, LY231514,MTA), gemcitabine, and oxaliplatin in human colorectal carcinoma cell lines. The 11th NCI-EORTC-AACR Symposium. Clin Cancer Res, 6:1078, 2000.

Responsible Party:	DiaTech Oncology ( Cary Presant, MD )
Study ID Numbers:	20050113
Study First Received:	October 20, 2005
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00243685 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by DiaTech Oncology:

Chemosensitivity
Chemotherapy
Lung cancer
Ovarian Cancer
Breast Cancer

Sarcoma
Apoptosis
MiCK Assay
New Technology
Patients with pathological diagnoses of breast, lung, and ovarian adenocarcinomas and soft tissue sarcoma

Study placed in the following topic categories:

Thoracic Neoplasms
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Sarcoma
Ovarian Cancer
Endocrinopathy
Adenocarcinoma
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases

Adnexal Diseases
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Sarcoma
Breast Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009