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A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms conditions. Clinical Trials Search.org is a site devoted 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 healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms 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 allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment 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 oftentimes recieve the best healthcare possible for their A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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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
Other Prostate Neoplasm Studies:
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2. Capecitabine Combined with Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
3. Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
4. Epothilone (ixabepilone) plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer
5. Vaccination Against Melanoma and Other Cancers
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A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms
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