Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis
This study has been completed.
Sponsor:
DiaTech Oncology
Information provided by:
DiaTech Oncology
ClinicalTrials.gov Identifier:
NCT00243685
First received: October 20, 2005
Last updated: January 25, 2012
Last verified: January 2012
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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
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 Neoplasms Lung Neoplasms Ovarian Neoplasms Sarcoma Neoplasms by Site Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013