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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
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2. Vaccination of Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype
3. A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma
4. Tissue Acquisition for Molecular Diagnostics
5. Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts
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A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
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