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BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction Clinical research trials and BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction clinical trial. Test subjects typically obtain the finest healthcare available for their BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction  BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
For Condition: small intestine cancer,Leukemia,Lymphoma,adult solid tumor
Status: Recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI),Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have advanced solid tumors or lymphomas and liver dysfunction.
Details: OBJECTIVES: - Determine the levels of hepatic impairment at which dose modifications of BMS-247550 are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction. - Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients. - Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction). Patients receive BMS-247550 IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 12-120 patients (12 for stratum I; 12-24 for stratum II; 12-36 for stratum III; and12-48 for stratum IV) will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective - Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma - Any solid tumor or lymphoma tumor type eligible - Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month - Prior whole brain or gamma knife radiotherapy required for known brain metastases - No unstable or untreated (non-irradiated) brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No active hemolysis Hepatic - See Disease Characteristics - Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable - Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes) - No evidence of biliary sepsis Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - No concurrent uncontrolled illness - No ongoing or active infection - No uncontrolled diarrhea - No peripheral neuropathy grade II or greater - No psychiatric illness or social situation that would preclude study compliance - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy for malignancy Chemotherapy - More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy for malignancy Endocrine therapy - See Disease Characteristics - No concurrent oral contraceptives - No concurrent hormone therapy for malignancy Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy for malignancy Surgery - More than 2 weeks since prior major surgery Other - Recovered from prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AngelaDavies, , University of California Davis Cancer Center
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Ramesh Ramanathan 412-648-6507
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Puget Sound Cancer Centers *Recruiting*
Seattle, Washington, 98133
United States
Recruiting Robert Livingston 206-288-1085
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting Stephen Williamson 913-588-6029
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Angela Davies 916-734-3771
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Anna Pavlick 212-263-6485
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Melanie Thomas 713-792-2828
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111 Ext 62960
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting S. Eckhardt 720-848-0300
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Chris Takimoto 210-562-1725
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Sridhar Mani 718-904-2488
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Daniel Mulkerin 608-262-9653
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Scot Remick 216-844-1196
Center for Cancer Research *Recruiting*
Bethesda, Maryland, 20889-5105
United States
Recruiting Jean Grem 301-435-5382
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Patricia LoRusso 313-745-8860
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98109-1023
United States
Recruiting Robert Livingston 206-288-2034
Additional Information:
Study ID Numbers: CDR0000258060; NYU-0132,NCI-5707,SWOG-S0355
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049400
Other Leukemia Studies:
1. Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
2. BMS-247550 in Treating Patients With Advanced Cancers
3. VNP40101M in Treating Patients With Advanced or Metastatic Cancer
4. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
5. Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
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BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
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