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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| 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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
| Enrollment: | 60 |
| Study Start Date: | December 2001 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
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 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| City of Hope National Medical Center / UCI Medical Center | |
| Pasadena, California, United States, 91105 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48202 | |
| 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 at University Hospitals Case Medical Center, Case Comprehensive 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 | |
| Study Chair: | Afshin Dowlati, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Afshin Dowlati, MD, : Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00026169 History of Changes |
| Obsolete Identifiers: | NCT00028392 |
| Other Study ID Numbers: | CWRU1Y01, U01CA062502, P30CA043703, CWRU-1Y01, NCI-02-C-0073, NCI-5340 |
| Study First Received: | November 9, 2001 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
recurrent adult brain tumor adult brain stem glioma unspecified adult solid tumor, protocol specific adult anaplastic oligodendroglioma adult mixed glioma gastrointestinal stromal tumor polycythemia vera Philadelphia chromosome positive chronic myelogenous leukemia meningeal chronic myelogenous leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia AIDS-related peripheral/systemic lymphoma anaplastic large cell lymphoma |
angioimmunoblastic T-cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma small intestine lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma |
|
Neoplasms Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Nervous System Neoplasms Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Central Nervous System Neoplasms |
Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Gastrointestinal Stromal Tumors Intestinal Neoplasms Myelodysplastic-Myeloproliferative Diseases Pathologic Processes Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |