|
Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer Clinical research trials and Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer. Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer  Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer
Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer
For Condition: Squamous Cell Carcinoma,Head and Neck Cancer,Head and Neck Neoplasm
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with recurrent or metastatic squamous cell carcinoma of the head and neck will be treated with flavopiridol, a cyclin-dependent kinase inhibitor given as a daily bolus for 5 days. The purpose of this study is to determine the activity of flavopiridol in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The primary endpoint will be to assess the "standard" response rate (CR/PR/MR) of this population receiving flavopiridol. Secondary endpoints will be to assess the progression-free survival, response duration and general toxicity of flavopiridol in this population. Translational endpoints include assessment of gene expression using microarray analysis of normal and neoplastic head and neck tissues (obtained by microdissection) before and during therapy, assessment of the modulation of signal transduction pathways and measurement of apoptosis induced by flavopiridol from these tissues, gene expression studies using array technologies from normal lymphocytes before and during therapy, measurement of plasma cytokines and determination of (18)F FDG uptake by PET scan before and after therapy.
Details: Patients with recurrent or metastatic squamous cell carcinoma of the head and neck will be treated with flavopiridol, a cyclin-dependent kinase inhibitor given as a daily bolus for 5 days. The purpose of this study is to determine the activity of flavopiridol in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The primary endpoint will be to assess the "standard" response rate (CR/PR) of this population receiving flavopiridol. Secondary endpoints will be to assess the progression-free survival, response duration and general toxicity of flavopiridol in this population. Translational endpoints include assessment of gene expression using microarray analysis of normal and neoplastic head and neck tissues (obtained by microdissection) before and during therapy, assessment of the modulation of signal transduction pathways and measurement of apoptosis induced by flavopiridol from these tissues, gene expression studies using array technologies from normal lymphocytes before and during therapy, measurement of plasma cytokines and determination of 18F FDG uptake by PET scan before and after therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must meet all of the following inclusion criteria: Histologically proven squamous cell carcinoma of the head and neck region that is either metastatic at diagnosis or has persisted, metastasized or recurred following definitive surgery and/or radiation therapy. Pathological confirmation of SCC of the head and neck at the treating institution is required. Patients must have bidimensionally measurable disease. All measurable disease must be documented within 2 weeks prior to registration. Patients must not have received more than three systemic chemotherapeutic regimens for recurrent or metastatic disease. Radiotherapy, surgery or chemotherapy must have been completed at least 4 weeks prior to entry and all toxicities must have resolved (in the opinion of the treating investigator). Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator). There must be no plans for the patient to receive concurrent radiotherapy, hormonal therapy (except oral contraceptives), biologic or other chemotherapy while receiving protocol treatment. No other prior malignancy is allowed except by the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. Age greater than or equal to 18 years. Performance Status ECOG 0-2. Ability to provide informed consent. Laboratory tests: SGPT and SGOT less than 2.5 x nl, total bilirubin less than 1.5 x nl, serum creatinine less than or equal to 1.5 mg/dl or if greater than 1.5, measured or calculated creatinine clearance greater than or equal to 60 ml/min), Calcium less than or equal to 1 x nl, platelets greater than 100,000 cells/ microl, absolute granulocyte count (AGC) greater than 1,500/microl. EXCLUSION CRITERIA: Patients with newly diagnosed non-metastatic disease and patients with only evaluable or unidimensional lesions Undifferentiated and non-keratinizing carcinomas including lymphoepitheliomas of all locations. Nasopharynx tumors. More than three systemic chemotherapeutic regimens for metastatic or recurrent disease Patients previously treated with flavopiridol History of CNS (metastatic or leptomeningeal) disease Positive HIV serology Pregnancy or nursing Hypercalcemia refractory to bisphosphonates (in the opinion of the treating investigator). Patients with a history of unstable or newly diagnosed angina pectoris, myocardial infarction within past 6 months and/or class II-IV congestive heart failure are not eligible. Previous or concurrent malignancy at other sites. For PET evaluation: Patients greater than or equal to 136 kg. (weight limit for scanner patient tables) For 18F-FDG PET only: less than 4 months after radiation therapy or poorly-controlled diabetes Patients with history of symptomatic carotid disease, prior carotid endarterectomy or other revascularization surgery Patients with asymptomatic 70% or more occlusion of one or both carotid arteries as determined by carotid Doppler ultrasound Patients unable to take Aspirin or Clopidogrel due to contraindications, allergies, or pre-existing medical conditions such as active peptic ulcer, aspirin-induced asthma, history of undiagnosed non-occult and non-hemorrhoidal gastrointestinal or other bleeding sources within the prior 6 months Any thrombotic event within the prior 6 months Active anti-coagulation with international randomized ratio (INR) greater than or equal to 1.5, low molecular weight heparins or its equivalents Known past medical history of hypercoagulopathies such as protein C deficiency, protein S deficiency, lupus anticoagulant, etc.
Total Enrollment: 37
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 000128; 00-C-0128
Study Start Date: May 20, 2000
Record last reviewed: March 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005670
Other Head And Neck Cancer Studies:
1. Recombinant Fowlpox Virus Vaccine to Treat Mouth and Throat Cancer
2. The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
3. A Phase I Study of Concomitant Therapy with Proteasome Inhibitor PS-341 and Radiation in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
4. A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer
5. Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer
|
|
|
|
|
|
|
|
