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Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms Clinical research trials and Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms. Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms clinical trial. Human subjects often get the best healthcare available for their Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms  Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms
Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms
For Condition: Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients receive depsipeptide by continuous IV infusion over 4 hours on days 1 and 5. Treatment is repeated every 21 days. In the absence of dose-limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of depsipeptide on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalating ceases and the next lower dose is declared the maximum tolerated dose. In the absence of progressive disease or severe toxicity, patients may continue treatment.
Details: NSC 630176 is a depsipeptide fermentation product from Chromobacterium Violaceum first isolated by the Fujisawa Company. It has demonstrated potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors. NSC 630176 shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and cyclophosphamide, however, it has been defined as a P-glycoprotein (Pgp) substrate by COMPARE analysis of the NCI drug screen cytotoxicity profile. Because of its activity and lack of cross resistance with several standard agents, this study will evaluate the toxicity and pharmacokinetics of NSC 630176 when given as a four hour infusion on days 1 and 5 of a 21 day cycle. Patients with neoplasms refractory to standard therapy or those for whom there is no known standard therapy that is potentially curative or capable of extending life expectancy, will be evaluated for study eligibility without consideration of race, ethnic origin, sex or sexual orientation. The starting dose of 1 mg/m(2), defined using 1/3 of the toxic dose low (TDL) in preclinical animal studies, will be escalated using a modified Fibonacci scheme, and toxicity endpoints will be evaluated using the NCI common toxicity criteria. In addition to the evaluation of the toxicity and pharmacokinetics of NSC 630176, the study will look for evidence of clinical antineoplastic activity of this compound and, when possible, mdr-1 expression will be measured in tumor biopsies before and after treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with histologic confirmation of an incurable solid tumor malignancy. Patients with no known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Patients with ECOG PS of 0, 1, 2, with no recent weight loss of greater than 10% of ABW. Patients age 18 years or older. Patients with the following lab values performed less than or equal to 14 days prior to registration: absolute neutrophil count greater than or equal to 1,000/microliter platelets greater than or equal to 100,000/microliter creatinine less than or equal to 1.5X upper limit of normal bilirubin (total and direct) less than or equal to 1.5X upper limit of normal AST less than or equal to 3X upper limit of normal PT/PTT less than or equal to 1.1X upper limit of normal ejection fraction greater than or equal to 45% by MUGA Scan or Echo cardiogram performed within six weeks of registration Patients with oral intake greater than or equal to 1,200 calories/day Patients with the willingness to return to the NCI for follow-up. Patients with with a life expectancy greater than 12 weeks. No patients with the following prior therapies: chemotherapy within the last 4 weeks prior doxorubicin with total dose greater than 360 mg/m2 nitrosourea/mitomycin-C within the last 6 weeks radiation therapy within 3 weeks of planned treatment with depsipeptide, or radiation to greater than 25% of bone marrow No patients with uncontrolled infection, including patients testing positive for HIV. No patients with history of cardiac disease including angina or coronary artery disease, congestive heart failure, valvular heart disease, arrhythmia or cardiomyopathy. Patients with equivocal cardiac histories or findings will be evaluated by Cardiology as to their suitability for enrollment. No patients that are pregnant or lactating. No men and women of reproductive potential not practicing adequate contraception. No patients with CNS metastases or history of CNS metastases. No patients with serious intercurrent illnesses such as seizure disorder, uncontrolled hypertension, or myelodysplastic syndrome. No patients with recent major surgery (within 21 days).
Total Enrollment: 48
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970135; 97-C-0135
Study Start Date: June 18, 1997
Record last reviewed: April 4, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001578
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Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC 630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients with Refractory Neoplasms
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