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506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment Clinical research trials and 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment. 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "5" Clinical Trials Conditions > 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment  506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
For Condition: Multiple Myeloma,Leukemia,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
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 506U78 in treating patients who have hematologic cancer and kidney or liver impairment.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of 506U78 in patients with hematologic malignancies and renal or hepatic impairment. II. Establish dosing guidelines for this drug in this patient population. III. Determine the toxicities and pharmacokinetics of this drug in these patients. PROTOCOL OUTLINE: Patients are stratified into 5 groups according to renal and hepatic function: Group 1: Normal renal function and normal hepatic function Group 2: Moderate renal impairment and normal hepatic function Group 3: Severe renal impairment and normal hepatic function Group 4: End stage renal impairment and normal hepatic function Group 5: Normal renal function and moderate hepatic impairment Group 1: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Groups 2-5: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Dose escalation occurs independently in each of the treatment groups. Cohorts of 3-6 patients receive escalating doses of 506U78 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 toxicities. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed hematologic malignancy that has failed standard therapy or for which no standard therapy exists, including, but not limited to, the following: Acute lymphocytic leukemia; Acute myelogenous leukemia Chronic lymphocytic leukemia; Chronic myelogenous leukemia; Multiple myeloma; Non-Hodgkin's lymphoma; Hodgkin's disease - No history of CNS disease, including carcinomatous meningitis --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy (e.g., interferon, monoclonal antibodies); No concurrent interleukin-11 for treatment or prevention of thrombocytopenia; No concurrent prophylactic colony stimulating factors - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for melphalan, carmustine, or mitomycin); At least 72 hours since prior hydroxyurea; No prior 506U78; No other concurrent chemotherapy - Endocrine therapy: At least 72 hours since prior glucocorticoids; Concurrent continuation of steroids for adrenal failure allowed; No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes); No concurrent dexamethasone or other steroidal antiemetics - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent palliative radiotherapy; No concurrent whole brain irradiation for documented CNS disease - Surgery: Not specified - Other: At least 72 hours since prior aspirin --Patient Characteristics-- - Age: 18 and over - Performance status: CTC 0-2 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin: Groups 1-4: Less than 1.5 times upper limit of normal (ULN); Group 5: 1.5-4 times ULN - Renal: Creatinine clearance: Groups 1 and 5: Greater than 50 mL/min; Group 2: 30-50 mL/min Group 3: Less than 30 mL/min; Group 4: Less than 30 mL/min, requiring dialysis - Neurologic: No history of grade 2 peripheral neuropathy; No history of seizure disorder; No history of neurologic dysfunction - Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ToddZimmerman, Study Chair, Cancer and Leukemia Group B
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Additional Information:
Study ID Numbers: CDR0000067483; CLB-69803
Study Start Date: December 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004239
Other Multiple Myeloma Studies:
1. Efficacy Study of 6474 to treat Multiple Myeloma Cancer
2. Thalidomide-Dexamethasone for Multiple Myeloma
3. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
4. Total Therapy II
5. Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure
Related Studies:
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506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
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