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A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833 Clinical research trials and A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833 medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833. A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833 Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833 clinical trial. Participants frequently obtain the most expert healthcare available for their A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833 condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833  A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833
A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833
For Condition: Breast Cancer,Kidney Neoplasm,Lymphoma,Neoplasm Metastasis,Ovarian Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.
Details: The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Biopsy proven metastatic cancer, for whom no better therapy exists. All patients are eligible. Enrollment of patients with kidney, breast, ovarian cancers, and lymphomas is encouraged. A life expectancy of at least 16 weeks, and a performance status (Karnofsky scale) of 70% or greater. Patients without rapidly growing disease. Any prior therapy except for previous bone marrow transplantation. WBC greater than 3,000/mm3 and ACG greater than 1,000/mm3; platelets greater than 100,000/mm3. Creatinine Clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; SGOT less than 70u/L; SGPT less than 80u/L. A signed informed consent and geographic accessibility for the patient to return for follow up and treatment. No history of brain metastases. Not currently receiving treatment with the following agents or any other agent known to significantly interact with cyclosporine, and treatment cannot be discontinued, or changed to another therapeutically equivalent allowable drug: acetazolamide, barbiturates, corticosteroids, diltiazem, erythromycin, fluconazole, ketoconazole, nicardipine, phenothiazines, phenytoin, rifampin, sulfonamides, trimethoprim, verapamil, tamoxifen, progesterone, quinine, quinidine, or amiodarone. No symptomatic peripheral neuropathy (grade 2 or greater arising from prior vinca alkaloid therapy). No positive serology for HIV. No ongoing pregnancy or unwillingness to practice adequate contraception.
Total Enrollment: 80
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 920268; 92-C-0268
Study Start Date: September 29, 1992
Record last reviewed: June 13, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001302
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2. A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.
3. Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients with Chest Wall Recurrence or Stage IV Disease with Locally Advanced Breast Cancer
4. Effects of Raloxifene on Hormone Levels
5. Decitabine in Treating Patients With Advanced Solid Tumors
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A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833
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