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| Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026169 |
Purpose
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.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Gastrointestinal Stromal Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: imatinib mesylate |
Phase I |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Intestinal Cancer Kidney Failure Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma |
| ChemIDplus related topics: | Imatinib Imatinib mesylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Pharmacokinetic Study Of STI571 In Patients With Advanced Malignancies And Varying Degrees Of Renal Dysfunction For The CTEP-Sponsored Organ Dysfunction Working Group |
| Study Start Date: | December 2001 |
OBJECTIVES:
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
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Any solid tumor, and especially:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |||||
| City of Hope Comprehensive Cancer Center | |||||
| Duarte, California, United States, 91010 | |||||
| City of Hope National Medical Center / UCI Medical Center | |||||
| Pasadena, California, United States, 91105 | |||||
| University of California Davis Cancer Center | |||||
| Sacramento, California, United States, 95817 | |||||
| USC/Norris Comprehensive Cancer Center and Hospital | |||||
| Los Angeles, California, United States, 90033-0804 | |||||
| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| United States, Michigan | |||||
| Barbara Ann Karmanos Cancer Institute | |||||
| Detroit, Michigan, United States, 48201 | |||||
| United States, New York | |||||
| Albert Einstein Clinical Cancer Center | |||||
| Bronx, New York, United States, 10461 | |||||
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |||||
| New York, New York, United States, 10016 | |||||
| United States, Ohio | |||||
| Ireland Cancer Center | |||||
| Cleveland, Ohio, United States, 44106-5065 | |||||
| United States, Pennsylvania | |||||
| University of Pittsburgh Cancer Institute | |||||
| Pittsburgh, Pennsylvania, United States, 15213-1863 | |||||
| United States, Texas | |||||
| University of Texas Health Science Center at San Antonio | |||||
| San Antonio, Texas, United States, 78229 | |||||
| United States, Wisconsin | |||||
| University of Wisconsin Comprehensive Cancer Center | |||||
| Madison, Wisconsin, United States, 53792 | |||||
| Ireland Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
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Gibbons J, Egorin MJ, Ramanathan RK, Fu P, Mulkerin DL, Shibata S, Takimoto CH, Mani S, LoRusso PA, Grem JL, Pavlick A, Lenz HJ, Flick SM, Reynolds S, Lagattuta TF, Parise RA, Wang Y, Murgo AJ, Ivy SP, Remick SC; National Cancer Institute Organ Dysfunction Working Group. Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of renal dysfunction: a study by the National Cancer Institute Organ Dysfunction Working Group. J Clin Oncol. 2008 Feb 1;26(4):570-6.
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Remick SC, Ramanathan RK, Mulkerin D, et al.: P-5340: a phase I pharmacokinetic study of STI-571 in patients (pts) with advanced malignancies and varying degrees of renal dysfunction. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-503, 2003.
  |
| Study ID Numbers: | CDR0000068993, CWRU-1Y01, NCI-02-C-0073, NCI-5340 |
| First Received: | November 9, 2001 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00026169 |
| Health Authority: | United States: Federal Government |
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