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Home > "B" Clinical Trials Conditions > BMS-214662 in Treating Patients With Solid Tumors  BMS-214662 in Treating Patients With Solid Tumors
BMS-214662 in Treating Patients With Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): M.D. Anderson Cancer Center , 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-214662 in treating patients who have solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors. - Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients. - Determine the nature of dose limiting toxicity of this drug in this patient population. - Determine the recommended phase II regimen of this drug in these patients. - Establish a pharmacologic and pharmacokinetic profile of this drug in these patients. OUTLINE: This is a dose escalation study. Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. 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 at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for at least 24 months. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of malignant solid tumor for which a standard curative therapy does not exist PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Karnofsky 70-100% Life expectancy: - At least 6 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST no greater than 2 times upper limit of normal - Albumin at least 3.0 g/dL Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No uncontrolled heart disease - No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation - Corrected QT interval no greater than 450 milliseconds Gastrointestinal: - Must not require total parenteral nutrition - No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No signs or symptoms of acute infection requiring systemic therapy - No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause - No confusion, disorientation, or psychiatric illness that may preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 3 prior chemotherapy regimens - At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered - No other concurrent antineoplastic agents Endocrine therapy: - No concurrent hormonal anticancer therapy Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - Not specified Other: - Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug - No drugs known to prolong the QT interval during and for 24 hours after study drug - No concurrent therapy with known CYP3A4 substrates - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ValiPapadimitrakopoulou, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067960; MDA-ID-99304,NCI-671
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005973
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
2. Anidulafungin in Treating Immunocompromised Children With Neutropenia
3. Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
4. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
5. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
BMS-214662 in Treating Patients With Solid Tumors
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