Status:
COMPLETED
Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis
Lead Sponsor:
Pierian Biosciences
Conditions:
Breast Neoplasms
Lung Neoplasms
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
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 techno...
Detailed Description
Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Solid Tumors DiaTech Oncology, LLC \----------------------------------------------------------- 1.0 B...
Eligibility Criteria
Inclusion
- 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
- 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the patient must not receive study medication and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study.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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00243685
Start Date
September 1 2006
End Date
May 1 2009
Last Update
January 26 2012
Active Locations (3)
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1
Nashville Breast Center
Nashville, Tennessee, United States, 37203
2
Nashville Oncology Associates
Nashville, Tennessee, United States, 37203
3
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229