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Home > "B" Clinical Trials Conditions > BMS-184476 in Treating Patients With Advanced Solid Tumors  BMS-184476 in Treating Patients With Advanced Solid Tumors
BMS-184476 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): San Antonio Cancer Institute ,
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-184476 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended phase II dose, and safety of BMS-184476 in patients with advanced solid tumors. II. Determine the pharmacokinetic profile of BMS-184476 and its metabolites in these patients. III. Determine preliminary evidence of antitumor activity of BMS-184476 in these patients. PROTOCOL OUTLINE: This is an open label, dose escalation study. Patients receive BMS-184476 IV over 1 hour. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. In the second part of the study, patients receive BMS-184476 IV over 1 hour weekly. Cohorts of 3-6 patients are treated at escalating doses of BMS-184476. The maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity. Patients are followed every 4 weeks until toxicity is resolved. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed advanced solid tumors refractory to conventional anticancer therapy, or for which no effective therapy exists - Measurable or evaluable disease - No active brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas, mitomycin, or carboplatin); Prior taxane therapy allowed; No other concurrent chemotherapy - Endocrine therapy: At least 1 week since prior steroid therapy; No concurrent hormonal therapy - Radiotherapy: At least 4 weeks since prior wide field radiotherapy (involving at least 30% of the bone marrow); No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent experimental anticancer medications --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; ALT and AST no greater than 2.5 times upper limit of normal (ULN) - Renal: Creatinine less than 1.5 times ULN - Cardiovascular: No uncontrolled or significant cardiovascular disease; No myocardial infarction within past 6 months; No congestive heart failure (with or without therapy); No history of atrial or ventricular arrhythmias; No history of second or third degree heart block - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No serious uncontrolled medical disorder or active infection; No known hypersensitivity to drugs containing Cremophor EL; No concurrent neurologic toxicity; No dementia or altered mental status
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ManuelHidalgo, Study Chair, San Antonio Cancer Institute
San Antonio Cancer Institute
San Antonio, Texas, 78229-3264
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Additional Information:
Study ID Numbers: CDR0000066813; UTHSC-9785011072,NCI-V98-1499,BMS-CA154-001,SACI-IDD-97-21
Study Start Date: November 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003705
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
2. EMD 121974 in Treating Patients With Advanced Solid Tumors
3. Interleukin-12 in Treating Patients With Advanced Cancer
4. Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
5. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other Fort Sam Houston Clinical Trials
BMS-184476 in Treating Patients With Advanced Solid Tumors
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