Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Standard Chemotherapy

Cary Presant, MD

A previous preliminary study performed at Vanderbilt University with funding from the Leukemia Society of America demonstrated that the response of leukemia cells in vitro to the chemotherapeutic agent idarubicin in the microculture kinetic assay for apoptosis (MiCK assay) predicted survival in patients with newly diagnosed acute myeloid leukemia (AML). In this previous study, achievement of complete response (CR) to induction therapy with idarubicin and cytarabine was used as the clinical indicator for determining whether leukemia specimens taken prior to treatment were sensitive or not sensitive in the MiCK assay. This group of patients has been followed for 7 years and their long term survival rates show that their responses in the MiCK assay to idarubicin but not cytarabine predict survival. In the present proposal a separate group of patients with newly diagnosed AML will be recruited to provide leukemia cell samples that will be used to establish criteria for sensitivity and non-sensitivity to idarubicin and cytarabine in the MiCK assay. The achievement of CR will be used to determine in vitro sensitivity as it was done in the previous study. With the in vitro sensitivities as determined in this proposed study, the long term survivals of patients in the previous study will be analyzed prospectively.

The proposed study is expected to have an approximate duration of one year. Patient population will include newly diagnosed AML patients with both de novo AML and AML arising from a previously diagnosed myelodysplastic syndrome. The study will not include patients with previously treated leukemia that has relapsed

A previous preliminary study performed at Vanderbilt University with funding from the Leukemia Society of America demonstrated that the response of leukemia cells in vitro to the chemotherapeutic agent idarubicin in the microculture kinetic assay for apoptosis (MiCK assay) predicted survival in patients with newly diagnosed acute myeloid leukemia (AML). In this previous study, achievement of complete response (CR) to induction therapy with idarubicin and cytarabine was used as the clinical indicator for determining whether leukemia specimens taken prior to treatment were sensitive or not sensitive in the MiCK assay. This group of patients has been followed for 7 years and their long term survival rates show that their responses in the MiCK assay to idarubicin but not cytarabine predict survival. In the present proposal a separate group of patients with newly diagnosed AML will be recruited to provide leukemia cell samples that will be used to establish criteria for sensitivity and non-sensitivity to idarubicin and cytarabine in the MiCK assay. The achievement of CR will be used to determine in vitro sensitivity as it was done in the previous study. With the in vitro sensitivities as determined in this proposed study, the long term survivals of patients in the previous study will be analyzed prospectively.

STUDY DESIGN

1. Recruit patients and assign them unique number at the time of sample collection. All samples and data will be recorded by unique number. The key to the unique numbers assigned to each patient will be kept by the principal investigators at Vanderbilt.
2. After obtaining informed consent, collect specimens from patients whose induction therapy will include cytarabine and idarubicin. Collect and ship to DiaTech by overnight courier fifty (50) bone marrow or peripheral blood \[if available, both bone marrow and peripheral blood\] specimens from newly diagnosed patients with AML. Newly diagnosed AML patients include those diagnosed de novo or arising from a previously diagnosed myelodysplastic syndrome, but do not include patients with previously treated leukemia that has relapsed. An adequate specimen for analysis will contain sufficient numbers of viable leukemia cells to perform the MiCK assay with 7 doses of cytarabine and 7 doses of idarubicin..
3. Each patient's clinically recognized predictors of leukemia treatment outcome will be recorded. These predictors include age, sex, presence or absence of preceding myelodysplastic syndrome, blood leukocyte count at diagnosis, percentage of leukemic cells in the blood, and leukemic cell karyotype.

Use of the MiCK Assay for Apoptosis in AML

Use of the MiCK Assay for Apoptosis to Predict Complete Remission in Acute Myeloid Leukemia

DiaTech Oncology and Vanderbilt University

Pierian Biosciences

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Digestive System Diseases

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

MiCK Assay

2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients for first-line treatment.

2.2 To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients in a third-line, refractory treatment setting (exclusive of anti-VEGF)

1. 0 Background and Rationale: Despite the use of aggressive treatment protocols, less than 10% of cancer patients with an advanced disease respond to the therapy. There is a variety of different cancer drug regimens, all of which have approximately the same probability of clinical effectiveness. Identification of those patients who will or will not respond to a specific chemotherapy is important for making decisions regarding chemotherapy regimens as well as alternative management approaches. A laboratory test that could help to determine the sensitivity of an individual patient's tumor cells to specific chemotherapeutic agents would be valuable in choosing the optimal chemotherapy regimen for that patient with an expectation of increasing the response rate to the therapy. Several types of in vitro assays that measure tumor cell survival following exposure to cytotoxic agents have been evaluated for their ability to predict chemotherapy outcomes. As a group, these assays are referred to as drug resistance assays. In a resistance assay, the surviving tumor cells can be detected directly by their exclusion or metabolism of specific dyes. Alternatively, since some of tumor cells are proliferating, their survival can be detected by measurement of DNA synthesis by radiolabeled precursor incorporation or demonstration of clonogenic potential by growth into colonies in semi-solid culture medium. In several clinical studies, these assays were useful in detecting drug resistance and in predicting a poor prognosis for cancer patients. However, these resistance assays cannot detect sensitivity of an individual patient's tumor cells to a specific drug. Therefore, new methods determining drug-sensitivity of the tumor cells of an individual patient and, thus, capable of both predicting a positive treatment outcome and guiding chemotherapy, would be of significant value.

Recently, Dr. Kravtsov has developed an automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells. Apoptosis is a distinct mode of cell death which occurs under physiological conditions and yet can be induced in malignant cells by chemical and physical factors including antitumor drugs. During the last decade, it has been recognized that chemotherapeutic agents exert their antitumor activity by triggering apoptosis in susceptible tumor cells. This implies that the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells. Unlike "resistance" assays that measure a fraction of cells surviving drug exposure, the MiCK assay measures a fraction of tumor cells killed by a chemotherapeutic agent via mechanism of apoptosis. Therefore the MiCK assay determines drug sensitivity, rather than resistance. Recently the MiCK assay has been shown to predict complete remission rate and survival in acute myeloid leukemia patients better than clinical criteria did. In a limited study, the MiCK assay has been used to direct chemotherapy of the leukemia patients .

The MiCK assay has also been used to study drug-induced apoptosis in solid tumors, including neuroblastoma and colon adenocarcinoma cell lines. More recent data accumulated by DiaTech has demonstrated that the MiCK assay can detect drug induced apoptosis in primary cultures of tumor cells isolated from patients with ovarian carcinoma, gastric carcinoma, metastatic breast cancer and high grade soft tissue sarcoma. Based on these data, we suggest that the MiCK assay may be used to detect drug sensitivity profiles of individual patients with various types of solid tumors. This, in turn, may provide a way to tailor chemotherapy to an individual patient's drug sensitivity profile, and, thus, improve treatment outcomes, decrease adverse effects of the chemotherapy, increase the quality of patient's life, and reduce the treatment cost.

Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas

Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas

Symptoms and General Pathology

Disease Progression

Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) test performed

An automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells; the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells.

MICK Assay

Allan Hallquist, MD

Recently an automated test for measuring cancer cell death in the presence of chemotherapy has been developed. This test has been called the MiCK assay during the ten year development phase and is now called Correct Chemo.

CorrectChemo provides the medical community and patients a way to determine the effects of different chemotherapies on individual cancer cells.

MiCK assay has been proven to have clinical usefulness in two studies. In one study using multiple types of cancer, physicians used the MiCK assay in 63% of the patients. If the physician used the results to prescribe the chemotherapy treatment, the patients' response rate, time to the disease getting worse, and overall survival were all significantly better compared to patients whose physicians did not use the results. In another study of breast cancer patients, physicians used the MiCK assay in 74% of patients. If the results were used when planning chemotherapy, response rate and time to the disease started getting worse were all significantly better compared to patients whose physicians did not use the results of the MiCK assay The purpose of this study is to compare the outcomes of patients who have had the MiCK assay (CorrectChemo) with tumor types, physician attitudes towards the test, and how the physicians used the test. This study will be gathering this data by reviewing medical charts.

The purpose of this study is to correlate the clinical outcomes of patients who have had the MICK assay with tumor type, physician attitudes towards the assay, and how physicians used the assay by using data in patient charts, and surveying physician attitudes.

Study Objectives:

1. To determine how often physicians use the MiCK assay results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
2. To determine physician attitudes towards the MiCK assay.
3. To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay. This will be correlated with pattern of physician use of the assay.

Treatment Plan:

1. The treating oncologist will provide demographic information (patient identifying number, sex, age, number of prior lines of therapy, performance status) and tumor information (cell type, stage, metastatic sites, goal of therapy, pre-assay planned therapy, and post-assay therapy chosen for
2. Tumor response, patient symptom response, time to progression on each chemotherapy regimen, and overall survival will be determined from the patient chart and will be correlated with MICK assay results.
3. Physicians will complete a questionnaire on attitudes towards usefulness of the assay.

Statistics

1. Investigators will correlate tumor response, symptom response, time to progression and overall survival with drug therapy with drug response in MICK assay for first chemo regimen after assay, and according to pattern of physician use of the assay.
2. We will accumulate physician attitudes toward usefulness of the assay.

Informed Consent Since this study has no risk to the patient, informed consent will not be needed. Physicians will have the option of participating, or not participating, in each patient. Physicians will be compensated for completing chart review and submitting data after the MiCK assay has been performed, and at 6,12 and 24 months after MiCK assay.

Data Collection from Physicians Data will include demographics and tumor characteristics and physician attitudes: I used the test to develop a treatment plan yes/no, I found the test useful yes/no, I found the test to be helpful in planning for palliative care yes/no, I found the test to be helpful in planning for hospice yes/no. I have these suggestions for improvement (free text response). Data will include at 6,12 and 24 months clinical outcomes as judged by the physician: Complete, Partial, Stable, Death, symptomatic improvement patient felt better same or worse. Data will include at time of progression, did doctor use the MiCK assay to plan the next treatment, try to get another MiCK assay, or use the assay to plan for palliative care or hospice.

Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)

Chart Review of Demographics and Clinical Outcomes and Physician Attitudes in Patients Who Have Received the Microculture Kinetic (MiCK) Apoptosis Test

To determine how often physicians use the MiCK assay (CorrectChemo)results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.

To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo.) This will be correlated with pattern of physician use of the assay.

To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo). This will be correlated with pattern of physician use of the assay.

To determine how often physicians use the MiCK assay (CorrectChemo) results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Breast Neoplasms

Sarcoma

Lung Neoplasms

Neoplasms, Connective and Soft Tissue

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Soft Tissue Sarcoma

Laboratory Assay

Chemotherapy doctor determined from results

Mick Assay

Pat Whitworth, MD

Alexander Zweibach, MD, PhD

Karl Rogers, MD

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.

Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis

Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Drug Testing Sensitivity of Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Use of the MiCK Assay for Apoptosis in AML	NCT00286845	Leukemia, Myelo...	Standard Chemot...	18 Years -	Pierian Biosciences
Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas	NCT00443196	Adenocarcinoma Ovarian Neoplas... Fallopian Tube ... Peritoneal Neop...	MiCK Assay	-	Pierian Biosciences
Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas	NCT00443196	Adenocarcinoma Ovarian Neoplas... Fallopian Tube ... Peritoneal Neop...	MiCK Assay	-	Pierian Biosciences
Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)	NCT02137811	Cancer	MICK Assay	-	Pierian Biosciences
Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis	NCT00243685	Breast Neoplasm... Lung Neoplasms Ovarian Neoplas... Sarcoma, Soft T...	Laboratory Assa... Mick Assay	18 Years - 85 Years	Pierian Biosciences
Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)	NCT02137811	Cancer	MICK Assay	-	Pierian Biosciences

Spots Global Cancer Trial Database for mick assay

Every month we try and update this database with for mick assay cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mick assay

Every month we try and update this database with for mick assay cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mick assay cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.