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A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms Clinical research trials and A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms. A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms  A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms
A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms
For Condition: Breast Cancer,Neoplasm,Prostate Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with relapsed or refractory neoplasms will be treated with escalating doses of perifosine, and alkylphospholipid modulator of signal transduction. The purpose of this study is to determine the maximum tolerated dose of perifosine given according to different oral loading and maintenance regimens in an effort to avoid gastrointestinal toxicity previously noted in initial Phase I experience with single doses, while seeking maximal sustained plasma levels. Patients with solid tumors for whom there are no effective "standard" therapeutic options will be studied. Patients with leukemia and/or lymphomas will not be studied in this trial. Pharmacokinetics will be obtained on all dose levels. Translational endpoints include: assessment of whether plasma from treated patients can inhibit purified phospholipase C, and induce apoptosis or alter histone H1 expression in U937 cells as potential surrogate markers of drug effect; and examination of phorbol-ester stimulated PKC activity in peripheral blood mononuclear cells.
Details: Patients with relapsed or refractory neoplasms will be treated with escalating doses of perifosine, an alkylphospholipid modulator of signal transduction. The purpose of this study is to determine the maximum tolerated dose of perifosine given according to different oral loading and maintenance regimens in an effort to avoid gastrointestinal toxicity previously noted in initial Phase I experience with single doses, while seeking maximal sustained plasma levels. Patients with solid tumors and non-Hodgkin's lymphoma, chronic lymphocytic leukemia and myelodysplastic syndrome (MDS) for whom there are no effective "standard" therapeutic options will be studied. Pharmacokinetics will be obtained on all dose levels. Translational endpoints include: increased p21 in buccal keratinocytes, peripheral blood mononuclear cells, and circulating tumor cells when accessible.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histologic diagnosis of solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia or myelodysplastic (MDS) confirmed by the Laboratory of Pathology, NCI. No effective standard therapeutic options, but requiring systemic therapy. Age greater than 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 mg/dl; 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 50,000/microliter, absolute granulocyte count (ACG) greater than 500/microliter, hemoglobin, greater than or equal to 9.0 g/dl. Greater than or equal to 4 weeks from radiation or chemotherapy and recovery from associated toxicities, and greater than or equal to 6 weeks from nitrosureas, mitomycin C, or bone seeking radioisotopes prior to entry. Patients treated with suramin should be greater than 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. Prostate cancer patients must have tumor progression during blockade of testicular and adrenal androgens, and flutamide or other anti-androgens must have been discontinued for at least 4 weeks without disease improvement prior to study entry. 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 with breast carcinoma receiving hormonal therapy must discontinue these medications greater than or equal to 4 weeks prior to study entry and show evidence of disease progression. Patients eligible, but with abnormal laboratory values, will be repeated at least 48 hours prior to starting therapy. There abnormalities will be followed on the sampling schedule. EXCLUSION CRITERIA: History of CNS neoplasms. Positive HIV serology. Pregnant or nursing. Patients with a history of unstable or newly diagnosed angina pectoris, myocardial infarction within the past 6 months and/or New York Heart Association (NYHA) class II-IV (symptomatic limitation inability to carry on physical activity) are not eligible. Recent acute or chronic gastrointestinal conditions (e.g., stomach ulcer, enteritis) that might predispose for intolerability or poor drug absorption. Allergic reaction to any medication with a structure similar to perifosine. Pre-existing retinal disease or pathologic baseline electrooculogram. Other serious intercurrent illnesses which in the opinion of the responsible investigator would hamper assessment of drug effect. Presence of cataracts which interfere with normal vision, or require medical intervention as determined during the baseline ophthalmologic examination.
Total Enrollment: 45
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990043; 99-C-0043
Study Start Date: February 16, 1999
Record last reviewed: May 25, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001799
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A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms
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