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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. Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
2. BCX-1777 in Treating Patients With Refractory Hematologic Cancer
3. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
4. Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
5. A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors
Related Studies:
Other adult solid tumor Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
BMS-247550 in Treating Patients With Advanced Cancers
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