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BMS-247550 in Treating Patients With Advanced Cancers Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on BMS-247550 in Treating Patients With Advanced Cancers conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Advanced Cancers Clinical research trials and BMS-247550 in Treating Patients With Advanced Cancers healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as BMS-247550 in Treating Patients With Advanced Cancers. BMS-247550 in Treating Patients With Advanced Cancers Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a BMS-247550 in Treating Patients With Advanced Cancers clinical trial. Human subjects often receive the most effective healthcare possible for their BMS-247550 in Treating Patients With Advanced Cancers condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Advanced Cancers  BMS-247550 in Treating Patients With Advanced Cancers
BMS-247550 in Treating Patients With Advanced Cancers
For Condition: small intestine cancer,Lymphoma,Leukemia,adult solid tumor
Status: Recruiting
Sponsor(s): University of Texas , National Cancer Institute (NCI)
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 malignantsolid tumors or lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies. - Determine the qualitative and quantitative toxic effects of this regimen in these patients. - Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. - Determine the antitumor effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to prior therapy (heavily pretreated vs minimally pretreated). Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 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 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course. Patients are followed within 1 month. PROJECTED ACCRUAL: Approximately 54 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant solid tumor or lymphoma for which no other potentially curative therapeutic option exists or demonstrates increased survival (considering tumor type, stage, and number of prior regimens) - No symptomatic brain metastases requiring dexamethasone - No progression or cerebral edema on CT scan or MRI within the past 4 weeks PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Neutrophil count at least 1,500/mm^3 - Hemoglobin at least 8.5 g/dL - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No atrial or ventricular arrhythmias requiring medication - No ischemic event within the past 6 months Other: - No pre-existing peripheral neuropathy greater than grade 1 - No other serious medical illness or active infection that would preclude study participation - No dementia, psychiatric illness, or other alteration in mental status that would preclude study compliance - No other active malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No history of allergy or hypersensitivity reaction to paclitaxel or other Cremophor EL-containing compound - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior anticancer hormonal therapy and recovered - No concurrent hormonal therapy except LHRH agonists for non-castrated prostate cancer, contraceptives, hormone replacement therapy (e.g., conjugated estrogens), or megestrol as an appetite stimulant Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - Concurrent palliative radiotherapy to limited sites allowed Surgery: - At least 4 weeks since prior surgery and recovered Other: - At least 30 days since prior investigational agents and recovered - No other concurrent experimental medications - No concurrent antiretroviral (HAART) therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricRowinsky, Study Chair, Cancer Therapy and Research Center
Cancer Therapy and Research Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Eric Rowinsky 210-616-5945
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Pamela New 210-617-5161
Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio, Texas, 78284
United States
Recruiting Caesar Tin-U 210-617-5300
St. Luke's Lutheran Hospital *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Lisa Hammond 210-617-7000
Additional Information:
Study ID Numbers: CDR0000068141; SACI-IDD-99-32,UTHSC-IDD-99-32,NCI-150
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006221
Other Adult Solid Tumor Studies:
1. BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
2. Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
3. Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis
4. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
5. Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
Related Studies:
Other adult solid tumor Clinical Trials
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BMS-247550 in Treating Patients With Advanced Cancers
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