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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction  Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
For Condition: adult solid tumor,Gastrointestinal Cancer,hematopoietic and lymphoid cancer
Status: No longer recruiting
Sponsor(s): University of Pittsburgh Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction. - Determine the effects of hepatic dysfunction on the pharmacodynamics and pharmacokinetics of this drug in these patients. - Determine the non-dose-limiting toxic effects of this drug in these patients. - Determine the response rate of these patients treated with this drug. - Correlate the Childs-Pugh classification of hepatic dysfunction with observed toxic effects, pharmacodynamics, and pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver dysfunction (normal vs mild vs moderate vs severe). Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients within each stratum (except normal 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed surgically incurable solid tumor or hematologic malignancy for which no standard or palliative therapy exists or is no longer effective - All tumor types are eligible, including: - Chronic myelogenous leukemia or other Philadelphia chromosome-positive leukemia OR - Gastrointestinal stromal tumors - Patients with gliomas that require corticosteroids or anticonvulsants must be on a stable dose and seizure-free for 1 month - No unstable or untreated (non-irradiated) brain metastases PATIENT CHARACTERISTICS: Age: - Over 15 (Patients 15 -18 years are eligible only if refractory disease and no alternative therapy options exist) Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 3 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 - No active hemolysis Hepatic: - See Surgery - No evidence of biliary sepsis Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Able to swallow pills - No other uncontrolled concurrent illness that would preclude study participation - No ongoing or active infection - No uncontrolled diarrhea - No psychiatric illness or social situation that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 6 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 24 hours since prior colony-stimulating factors - No concurrent colony-stimulating factors Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics - At least 10 days since prior placement of shunt for treatment of biliary obstruction - At least 14 days since prior major surgery - No prior solid organ transplantation Other: - No other concurrent investigational agents - No concurrent therapeutic doses of warfarin for anticoagulation - No other concurrent investigational or commercial agents or therapies for treatment of this disease - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent acetaminophen of more than 4,000 mg/day
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RameshRamanathan, Study Chair, University of Pittsburgh Cancer Institute
City of Hope Medical Group
Pasadena, California, 91105
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033
United States
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 California Davis Cancer Center
Sacramento, California, 95817
United States
Additional Information:
Study ID Numbers: CDR0000068959; MB-NAVY-B01-053,NCI-02-C-0020,NCI-5331,PCI-01-028
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025415
Other Hematopoietic And Lymphoid Cancer Studies:
1. Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer
2. Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer
3. Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
4. Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
5. BCX-1777 in Treating Patients With Refractory Cancer
Related Studies:
Other hematopoietic and lymphoid cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
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