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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure  Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
For Condition: Gastrointestinal Cancer,hematopoietic and lymphoid cancer,adult solid tumor,central nervous system cancer
Status: Completed
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by stopping the enzyme necessary for cancer cell growth. Kidney failure may delay the elimination of imatinib mesylate from the body, which may lead to longer drug exposure and increase toxic side effects. PURPOSE: Phase I trial to determine the dose of imatinib mesylate that is most effective with the least amount of toxic side effects in treating patients who have advanced cancer and kidney failure.
Details: OBJECTIVES: - Determine the maximum tolerated dose of imatinib mesylate in patients with advanced malignancies and varying degrees of renal dysfunction. - Determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of this drug in these patients. - Determine the safety of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to creatinine clearance (at least 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs less than 20 mL/min vs any creatinine clearance and undergoing dialysis). Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each stratum receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 60-69 patients (about 12 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which no standard curative therapy exists or palliative measures are no longer effective - Hematological malignancies - Philadelphia chromosome-positive patients should be enrolled on another NCI or Novartis trial, if possible - Myeloproliferative disorders - Any solid tumor, and especially: - Gastrointestinal stromal tumors - Gliomas - No untreated (unirradiated) or unstable brain metastases PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm OR - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - AST/ALT no greater than 1.5 times upper limit of normal Renal: - Abnormal kidney function allowed Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No seizures within the past month (for patients with glioma) - No other concurrent uncontrolled illness that would preclude study entry - No ongoing or active infection - No psychiatric illness or social situation that would preclude study consent - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior immunotherapy allowed - No concurrent colony-stimulating factor therapy Chemotherapy: - More than 24 hours since prior hydroxyurea to maintain WBC count in leukemia patients - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: - Prior hormonal therapy allowed - Concurrent corticosteroids must be at a stable dose - No concurrent oral contraceptives Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery: - No prior liver, kidney, or lung transplantation - At least 14 days since prior major surgery (e.g., thoracotomy or intra-abdominal surgery) Other: - Prior imatinib mesylate allowed - No other concurrent investigational agents - No concurrent therapeutic doses of warfarin - No concurrent tacrolimus or cyclosporine as an immunosuppressive agent - No concurrent herbal supplements, vitamins, or other nontraditional compounds - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent acetaminophen of more than 4,000 mg total daily dose - Concurrent anticonvulsants must be at a stable dose - Concurrent renal dialysis allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScotRemick, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-1863
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
City of Hope National Medical Center / UCI Medical Center
Pasadena, California, 91105
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Additional Information:
Study ID Numbers: CDR0000068993; NCI-02-C-0073,NCI-5340,CWRU-1Y01
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026169
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Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
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