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Home > "B" Clinical Trials Conditions > BMS-214662 in Treating Patients With Advanced Solid Tumors  BMS-214662 in Treating Patients With Advanced Solid Tumors
BMS-214662 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , Dana-Farber/Harvard Cancer Center
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-214662 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of BMS-214662 in patients with advanced solid tumors. II. Determine the safety of an appropriate dose of this drug for phase II studies. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the extent and duration of farnesyltransferase inhibition in peripheral blood mononuclear cells and other relevant surrogate markers of pharmacological activity of this drug in these patients. V. Determine any preliminary evidence of antitumor activity of this drug in these patients. VI. Determine pharmacodynamic relationships for the pharmacological effect of this drug upon surrogate markers of activity and host toxicity in these patients. VII. Compare the toxicity profiles for the 1-hour vs 24-hour IV infusions of this drug in these patients. PROTOCOL OUTLINE: This is a dose-prolongation, dose-escalation study. Single patient cohorts receive BMS-214662 IV over escalating periods of 2, 4, 8, 16, and 24 hours weekly for 3 weeks followed by 1 week of rest. If no patient experiences dose-limiting toxicity (DLT), dose escalation proceeds in the single patient cohorts. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Individual patient cohorts may increase their duration of BMS-214662 infusion in subsequent courses to the current duration safely reached. Beginning with the infusion level at which DLT is first encountered by a single patient, cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. An additional cohort of 10 patients is treated at the MTD. Patients are followed for at least 4 weeks. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of metastatic or inoperable malignancy for which no known curative or survival prolonging palliative therapy exists or which has failed these therapies No leukemia or primary CNS tumor No active brain metastases, including cerebral edema by CT scan or MRI, progression from prior imaging study, requirement for steroids, or clinical symptoms --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 3 weeks since prior major surgery Other: - At least 7 days since prior substrates of cytochrome P450-3A4 (CYP3A4), including terfenadine, astemizole, triazolam, midazolam, cisapride, bepridil, rifabutin, simvastatin, lovastatin, and propafenone - No substrates of CYP3A4 during and for at least 1 week after study - No non-steroidal anti-inflammatory drugs or other potentially nephrotoxic medications for at least 2 days before, during, and for at least 2 days after study drug administration --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) - Bilirubin no greater than ULN Renal: - Creatinine no greater than ULN - Creatinine clearance at least 50 mL/min - No known pre-existing renal disease Cardiovascular: - No clinically significant atrial or ventricular arrhythmias - No second- or third-degree heart block or prolonged QTc interval (greater than 450 ms) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled serious medical or psychiatric illness
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephEder, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000068170; NCI-67,DFCI-00003
Study Start Date: November 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006242
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
2. Epothilone D in Treating Patients With Advanced Solid Tumors
3. Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy
4. Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
5. BMS-184476 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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BMS-214662 in Treating Patients With Advanced Solid Tumors
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