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

Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis

This study has been completed.
Sponsor:
Information provided by:
DiaTech Oncology
ClinicalTrials.gov Identifier:
NCT00243685
First received: October 20, 2005
Last updated: January 25, 2012
Last verified: January 2012
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Drug Testing Sensitivity of Solid Tumors

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 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
Study Completion Date: May 2009
Arms Assigned Interventions
Experimental: II and III
Not applicable
Other: Laboratory Assay
Chemotherapy
Other Name: Comparison of differnt drugs
Other: Mick Assay
Chemotherapy doctor determined from results
Other Name: Chemotherapy

  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
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: NCT00243685

Locations
United States, Tennessee
Nashville Breast Center
Nashville, Tennessee, United States, 37203
Nashville Oncology Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229
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:
No publications provided

Responsible Party: Cary Presant, MD, DiaTech Oncology
ClinicalTrials.gov Identifier: NCT00243685     History of Changes
Other Study ID Numbers: 20050113
Study First Received: October 20, 2005
Last Updated: January 25, 2012
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

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasms
Ovarian Neoplasms
Sarcoma
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Lung Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Ovarian Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014