Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis

NCT00243685 | Completed Phase 2

• 1 other identifier: 20050113
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Breast Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Sarcoma, Soft Tissue

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  After chemotherapy

• To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients

  after chemotherapy

Study Arms (1)

II and III

EXPERIMENTAL

Other: Laboratory Assay; Other: Mick Assay

Interventions

Laboratory Assay OTHER

Chemotherapy

Also known as: Comparison of differnt drugs

II and III

Mick Assay OTHER

Chemotherapy doctor determined from results

Also known as: Chemotherapy

II and III

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierian Biosciences: lead

Study Sites (3)

Nashville Breast Center

Nashville, Tennessee, 37203, United States

Location

Nashville Oncology Associates

Nashville, Tennessee, 37203, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Sarcoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 24, 2005
• Study Start: September 1, 2006
• Study Completion: May 1, 2009
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

US (3)