|
Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction Clinical research trials and Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction. Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction clinical trial. Human subjects often obtain the finest healthcare possible for their Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction  Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction
Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction
For Condition: Liver Dysfunction,Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine a safe dose of imatinab (also known as STI571 and Gleevec® (Registered Trademark)) that can be given to cancer patients whose livers are not working normally. The liver helps eliminate drugs from the body. Patients with abnormal liver function may require lower doses of some drugs or may not be able to use others at all. Imatinab is approved for patients with chronic myeloid leukemia and has shown activity against other leukemias and stomach and intestinal tumors. Its effect in other cancers is not known. Patients 18 years of age and older with any type of advanced cancer that cannot be treated successfully with surgery or other standard therapies may be eligible for this study. Patients with normal liver function or with mild, moderate or severe dysfunction may participate. Candidates will be screened with imaging studies, such as X-rays, CT or MRI scans and blood tests. Women who are able to have children will have a pregnancy test. Participants will take imatinab by mouth once a day. The initial dose will be increased gradually in succeeding groups of patients until the highest safe dose is determined. Patients will be hospitalized for the first few days of treatment and again for one night on day 15 of the treatment to allow for blood sampling and evaluation. An individual's dose may be raised or lowered depending on side effects. Patients will have the following tests and procedures to evaluate side effects and the response to treatment: - Physical examinations - X-rays or CT scans to check the status of the cancer - Blood tests for routine chemistries, blood counts and evaluation of liver and kidney function - Blood and urine tests to measure drug levels - Bone marrow aspiration (in some leukemia patients) Treatment will continue for as long as the tumor shrinks or remains stable in size and the side effects are tolerable. The treatment will be stopped if the tumor grows, if side effects are too severe, or if the patient chooses to stop.
Details: This protocol will evaluate the safety and pharmacokinetic profile of imatinib (Gleevec formerly known as STI571) in patients with liver dysfunction. The degree of liver dysfunction will be based on the: Group A, Normal: bilirubin and SGOT less than or equal to upper limits of normal (ULN); Group B, Mild: T. bilirubin less than or equal to 1.5 x ULN and/or SGOT greater than ULN (can be normal or less than ULN if T. Bilirubin is greater than ULN); Group C, moderate: T. Bilirubin greater than 1.5 -3 X ULN, any SGOT; Group D, Severe: T. Bilirubin greater than 3 -10 X ULN, any SGOT. Doses will be escalated within each Group using a two-stage procedure using cohorts of 3 patients per dose level in the first stage and 6 patients per dose level in the second stage. Pharmacokinetic sampling will be obtained following the first dose and will be repeated on day 15.
Eligibility:
Study Type: Interventional,�Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have histologically or cytologically confirmed surgically incurable solid or hematological malignancy, and for which standard curative or palliative measures do not exist or are no longer effective. All tumor types are eligible. Patients with gliomas who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for one month prior to enrollment. Patients with brain metastasis should have had brain irradiation. ECOG performance status less than or equal to 2. Age greater than 18 years old. Life expectancy of greater than 3 months. Patients must have acceptable renal and marrow function as defined below: Leukocytes greater than or equal to 3,000/microliters; Absolute neutrophil count greater than or equal to 1,500 microliters; Platelets greater than or equal to 100,000 microliters; Creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal. Patients with abnormal liver function will be allowed. Active hemolysis should be excluded. Patients with biliary obstruction for which a shunt has been placed are eligible provided the shunt is in place for at last 10 days prior to the first dose of STI571. There should be no evidence of biliary sepsis. Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Since interaction with STI571 and oral contraceptives is possible, a barrier method should be used and oral contraceptives should not be the only method. A negative pregnancy test is required prior to starting therapy for women of child bearing age. Ability to swallow a pill. Patients must be capable of following instructions regarding taking study medication and completing medication diaries, or must have a caregiver who will be responsible for administering study medication and completing the diaries. Ability to understand and the willingness to sign a written informed consent document. Both men and women and members of all ethnic groups are eligible for this trial. EXCLUSION CRITERIA: Patients must not have had chemotherapy or radiotherapy within 4 weeks (6 weeks of nitrosoureas or mitomycin C) prior to entering the study and patients must have recovered from adverse events due to agents administered more than 4 weeks earlier. Patients may not be receiving any other investigational agents. Patients with unstable or untreated (irradiated) brain metastases should be excluded. Patients who have had solid organ transplants due to potential interaction with concomitant medications. Patients taking therapeutic doses of warfarin for anticoagulation due to potential interaction with STI571. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diarrhea, or psychiatric illness/social situation that would limit compliance with study requirements. Pregnant women are excluded from this study because STI571 is an agent with the potential for teratogenic or abortifacient effects. Women must not be breastfeeding if treated with STI571. HIV-patients must not be receiving combination anti-retroviral therapy. Patients must not have had a major surgery within 14 days prior to registration/treatment.
Total Enrollment: 60
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 020020; 02-C-0020
Study Start Date: October 31, 2001
Record last reviewed: September 26, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025948
Other Neoplasm Studies:
1. Irinotecan in Treating Patients with Refractory Solid Tumors and Liver Dysfunction
2. Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction
Related Studies:
Other Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction
|
|
|
|
|
|
|
|
