Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
|First Received Date ICMJE||February 28, 2003|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||February 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00055380 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients|
|Official Title ICMJE||Molecular, Genetic, and Biochemical Effects Of Novel Therapies In Buccal Mucosal Cells|
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:
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 undergo tumor biopsy, if accessible or available.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: Oral cytobrushing|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients (male, female, greater than or equal to age 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.
Patients unable to undergo cytobrushing (significant mucositis).
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.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00055380|
|Other Study ID Numbers ICMJE||030115, 03-D-0115|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Dental and Craniofacial Research (NIDCR)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP