|
Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients Clinical research trials and Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients. Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients clinical trial. Human subjects often obtain the finest healthcare possible for their Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients  Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
For Condition: Cancer
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: This study will examine the effects of certain investigational anti-cancer drugs on the genetic and protein makeup of cells. The findings will be entered into a database that may be used to: 1) determine the optimal dose of drug that will provide the most benefit with the least harmful side effects; and 2) predict which patients will have a greater chance of developing side effects or a greater chance of benefiting from the drug. Patients 18 years of age and older who are receiving the anti-cancer drugs flavopiridol or perifosine in an NIH clinical trial may be eligible for this study. Participants will undergo the following procedures both before starting treatment and during the first treatment cycle to look for genetic or chemical changes produced in response to the study drug: - Blood draws. - Buccal cell brushings: Collection of buccal cells (cells lining the inside of the cheeks) from the inside of the cheeks using a soft bristle brush for a few seconds several times. The patient then rinses the mouth with salt water for 1 minute and then spits into a cup. - Buccal cell biopsies (on both sides of the mouth): For this procedure, a local anesthetic is given to numb the biopsy area. Then, a small piece of tissue from the inner lining of the mouth is removed with a small sharp cookie-cutter instrument. The biopsy findings will be compared with those of the cheek brushings to see if the information is similar. - Tumor biopsies: In patients whose tumor is easily accessible, such as the skin abdominal fluid, tissue biopsies will be requested. Depending on the type and location of the tumor, the biopsy may be done with a forceps, a large needle (needle biopsy), a cookie-cutter instrument (punch biopsy), or a small knife (excisional biopsy). All of these procedures are done with a local anesthetic.
Details: A significant problem in drug development of novel small molecules is the lack of available tissues (surrogate tissues) that allow for the assessment of the molecular and biochemical effects of (targeted-therapies) drug action. The information obtained from surrogate tissues might help us validate previous preclinical studies with those agents and also dose them in a more rational way. Oral keratinocytes, which are accessible by non-invasive means, might be useful to assess drug action. The proposed study seeks to investigate the genetic, molecular, and biochemical effects of novel agents in oral buccal mucosal cells. Patients already enrolled in Phase I and II clinical trials for neoplastic diseases at the Clinical Center will undergo oral cytobrushing before and during therapy to determine the molecular and biochemical effects of novel agents in the oral mucosa cells. Similar studies will be performed in peripheral blood mononuclear cells. In order to validate to compare and compare the oral cytobrush methodology, some of these subjects will undergo oral punch biopsy studies. Some of these subjects will also under tumor biopsy, if accessible or available.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients (male, female, greater than or equal to 18 years) enrolled in a clinical trial at the Clinical Center receiving novel small molecules that modulate cell cycle progression for the prevention and treatment of neoplastic diseases. Able to sign informed consent. Patient's primary NIH physician should agree with appropriateness of patient's participation in the study. EXCLUSION CRITERIA: Patients unable to undergo cytobrushing (significant mucositis). Non-compliant patients. Patients unable to provide baseline samples (patients already receiving therapy). Exclusion for biopsy only: patients with significant bleeding diathesis, receiving active anticoagulation or with platelets less than 10K. Cognitively impaired subjects will be excluded from this trial.
Total Enrollment: 120
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030115; 03-D-0115
Study Start Date: February 26, 2003
Record last reviewed: October 30, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055380
Other Cancer Studies:
1. Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
2. Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer
3. Biomarkers of Benzene Exposure in Inner City Residents
4. Pesticides--Health Fertility and Reproductive Risk
5. Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
Related Studies:
Other Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
|
|
|
|
|
|
|
|
