|
A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms Clinical research trials and A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms. A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms  A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
For Condition: Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with relapsed or refractory neoplasms will be treated with escalating doses of flavopiridol, a cyclin-dependent kinase inhibitor (CDK), given as a daily bolus for 3 days. The purpose of this study is to determine the maximum tolerated dose (MTD) of flavopiridol in patients in whom there are no other standard therapeutic options. Pharmacokinetics will be obtained on all dose levels. Translational endpoints include the measurement of plasma cytokines and the detection of apoptosis in normal lymphocyte subpopulations. Tumor samples, when available, will be evaluated for the expression of cell cycle regulated proteins [cyclins, cyclin-dependent kinases (CDKs), cyclin-dependent kinase inhibitors, and phosphorylated substrates of CDKs], and measurement of apoptosis and tumor proliferation. Moreover, mRNA will be extracted from tumors and normal lymphocytes to assess differential expression using cDNA microarray analysis of gene expression.
Details: Patients with relapsed or refractory neoplasms will be treated with escalating doses of flavopiridol, a cyclin-dependent kinase inhibitor (CDK), given as a daily bolus for 5 days. The purpose of this study is to determine the maximum tolerated dose (MTD) of flavopiridol in patients in whom there are no other standard therapeutic options. Pharmacokinetics will be obtained on all dose levels. Translational endpoints include the measurement of plasma cytokines and the detection of apoptosis in normal lymphocyte subpopulations. Tumor samples, when available, will be evaluated for the expression of cell cycle regulated proteins [cyclins, cyclin-dependent kinases (CDKs), cyclin-dependent kinase inhibitors, and phosphorylated substrates of CDKs], and measurement of apoptosis and tumor proliferation. Moreover, mRNA will be extracted from tumors and normal lymphocytes to assess differential expression using cDNA microarray analysis of gene expression.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Histologic diagnosis of a solid tumor or lymphoma confirmed by the Laboratory of Pathology, NCI. No standard therapeutic options and requires systemic therapy. 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 or equal to 2.5 x nl, total bilirubin less than or equal to 1.5 x nl (in patients with clinical evidence of Gilbert's disease, less than or equal to 3 x nl), serum creatinine less than or equal to 1.5 mg/dl or if greater than 1.5, measured creatinine clearance greater than or equal to 60 ml/min), platelets greater than or equal to 75,000/ml, and absolute granulocyte count (AGC) greater than or equal to 1,000/ml. Greater than or equal to 4 weeks from radiation or chemotherapy and recovery from associated toxicities, and greater than or equal to 6 weeks nitrosureas, mitomycin C, or bone seeking radioisotopes prior to entry. No serious intercurrent medical illness. Prostate cancer patients must have tumor progression during blockade of testicular and adrenal androgens, and flutamide or other anti-androgens must have been discontinued greater than or equal to 4 weeks without disease improvement prior to study entry and PSA elevation on 2 consecutive blood samplings, 2 weeks apart. Leuprolide or other GnRh analogs should be maintained in patients without an orchiectomy, and all prostate cancer patients must have serum testosterone concentrations in the castrate range. Patients treated with suramin should be greater than or equal to 3 months from the last day of treatment. Patients treated with UCN-01 should be greater than or equal to 2 months from the last day of infusion. Patients with breast carcinoma receiving hormonal therapy must discontinue these medications 4 weeks prior to study entry without evidence of disease improvement. No prior flavopiridol treatment. No history of CNS neoplasms. Negative HIV serology. Not be pregnant or nursing. Must have a negative history of unstable or newly diagnosed angina pectoris, myocardial infarction within the past 6 months and/or class New York Heart Association (NYHA) II-IV (slight, marked limitation and inability to carry on physical activity, respectively). No patients with active coagulopathy requiring therapeutic anticoagulation.
Total Enrollment: 60
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970171; 97-C-0171
Study Start Date: August 26, 1997
Record last reviewed: March 19, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001585
Other Neoplasm Studies:
1. Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials
2. Clinical Evaluation of a Laser Heated, Fiberoptic-Coupled Radiation Dose Verification System
3. Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Kidney Dysfunction
4. Psychological Benefits of a Normalized Camping Experience for Children with Cancer and HIV Infection
5. Vaccination of Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype
Related Studies:
Other Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
|
|
|
|
|
|
|
|
