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Home > "P" Clinical Trials Conditions > Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Kidney Dysfunction  Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Kidney Dysfunction
Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Kidney Dysfunction
For Condition: Neoplasm,Kidney Failure
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine a safe dose of imatinab (also known as STI571 and Gleevec) for cancer patients whose kidneys are not working normally. The kidney helps eliminate drugs from the body. Patients with abnormal kidney 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 mild, moderate or severe kidney dysfunction may participate. Candidates will be screened with imaging studies, such as X-rays, CT or MRI scans, and blood tests. Women of childbearing potential will have a pregnancy test. Pregnant women may not participate in the study. Participants will take imatinab by mouth on day 1 of the study followed by a 2-day break to see how long the drug stays in the body. From day 4 on, patients will take imatinab once a day. A 24-hour urine sample will be collected on day 1, and blood samples will be drawn on days 1, 2, 3 and 4. On day 1, blood will be drawn just before the drug is administered, then at 7 time points after the drug is given. Two samples will be drawn on day 2 and one sample on the mornings of days 3 and 4. A total of about 7 tablespoons of blood will be drawn over the 4 days. Blood sampling will be repeated on days 15 and 16. Participants will be hospitalized the first few days of the study and overnight on day 15 to allow for the blood draws and evaluation. The initial drug dose will be increased gradually in succeeding groups of patients until the highest safe dose is determined. An individual's dose may be raised or lowered depending on side effects. In addition to the blood and urine tests described above, patients will have the following procedures to evaluate drug side effects and the response to treatment: - Physical examinations. - X-rays, CT, MRI or other scans (about every 8 weeks) to check the status of the cancer. - Blood draws for routine tests and to check blood cell counts and liver and kidney function. Patients will keep a record of the type and duration of drug side effects they experience. Treatment will continue as long as the side effects are tolerable and the tumor shrinks or remains stable in size. 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 renal dysfunction. The degree of renal dysfunction will be based on the creatinine clearance as follows: Group A, Normal: 60 mL/min; Group B, mild: 40-59 mL/min; Group C, moderate: 20-39 mL/min; Group D, severe: less than 20 mL/min; Group E, renal dialysis: any calculated creatinine clearance recorded on 2 occasions. 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.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have histologically or cytologically confirmed malignancy, which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. The following tumor types are eligible: 1. Chronic myelogenous leukemia and other Philadelphia chromosome - positive leukemia or myeloproliferative disorders. Patients with Philadelphia chromosome - positive leukemia should be enrolled in other NCI or Novartis sponsored trials, if possible; 2. Any solid tumor patient with abnormal renal dysfunction and including 12 patients with normal renal function (controls for pharmacokinetics) with an emphasis on patients with gastrointestinal stromal tumors (GIST) and including patients with glioma. Patients with glioma who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for one month prior to enrollment. Prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed, including prior therapy with STI571. There is no ceiling on number of prior regimens. Age greater than or equal to 16 years. ECOG performance status must be less than or equal to 2, (Karnofsky greater than or equal to 60%) and a life expectancy of at least 3 months. Patients must have adequate organ and marrow function as defined as leukocytes greater than or equal to 3,000/microliter, OR absolute neutrophil count greater than or equal to 1,500/microliter, platelets greater than or equal to 100,000/microliter, total bilirubin within normal institutional limits, AST (SGOT)/ALT(SGPT) less than or equal to 1.5 times the institutional upper limit of normal. Patients with abnormal kidney function will be allowed and will be grouped accordingly. Patients with gliomas and brain metastases, 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. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a women become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Pregnant women are not eligible. Breastfeeding should be discontinued if the mother is treated with STI571. Ability to understand and the willingness to sign a written informed consent form. Patients must be capable of following instructions regarding study medication, completion of medication diaries, or have a caregiver who will be responsible for administering study medication and completing medication diaries. EXCLUSION CRITERIA: Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study enrollment. Patients undergoing therapy with other investigational agents. Patients on therapeutic doses of warfarin are excluded. Patients who have had liver, kidney, lung transplants or are taking FK-506, cyclosporine as an immunosuppressive agent. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant and nursing women are excluded from this study. Breast feeding should be discontinued if the mother is treated with STI571 HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study. Patients receiving renal dialysis treatments while on the study will be enrolled in two cohorts per the schema. Patients must not have had a major surgery (e.g., thoracotomy, intra-abdominal surgery) within 14 days prior to registration. Patients with unstable or untreated (irradiated) brain metastases should be excluded.
Total Enrollment: 69
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 020073; 02-C-0073
Study Start Date: December 13, 2001
Record last reviewed: October 15, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028392
Other Kidney Failure Studies:
1. Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
2. Vascular Access Clinical Trials Data Coordinating Center
3. Prospective Controlled Study of Posttransplant Diabetes
4. Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Kidney Dysfunction
5. Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
Related Studies:
Other Kidney Failure Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Kidney Dysfunction
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