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Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis Clinical research trials and Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis. Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis clinical trial. Subjects often receive the most expert healthcare possible for their Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis
Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis
For Condition: Leukemia,Eye Cancer,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 tumor cells from dividing so they stop growing or die. Irinotecan may be effective in treating patients with abnormal liver or kidney function or who have received radiation therapy. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients with solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous radiation therapy to the pelvis.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan in patients with solid tumors or lymphoma who have liver or renal dysfunction or have had prior pelvic radiation. II. Characterize the pharmacokinetics of irinotecan in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients are stratified according to prior pelvic radiation therapy (yes vs no). Patients with no prior pelvic radiation are further stratified according to AST, bilirubin, and creatinine levels. Patients receive irinotecan IV over 90 minutes every 3 weeks for a total of 2 courses. After patients are reevaluated, treatment may continue in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of irinotecan. Dose escalation proceeds within each stratum until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study at a rate of 2-3 patients per month.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven solid tumors or lymphoma refractory to standard therapy or for which no standard therapy exists - Brain metastases allowed if following criteria met: Asymptomatic; Received prior therapy for brain metastases; Stable for at least 2 months; No concurrent steroid therapy --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent colony stimulating factors - Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since melphalan or mitomycin); At least 3 months since suramin; No prior nitrosoureas or irinotecan - Endocrine therapy: No concurrent steroids (except as antiemetic for chemotherapy) - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: At least 4 weeks since major surgery - Other: No concurrent medications known to affect hepatic or renal function (e.g., antiseizure medication or nonsteroidal antiinflammatory drugs) --Patient Characteristics-- - Age: 18 and over - Performance status: CALGB 0-2 - Life expectancy: Not specified - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic and Renal: Albumin at least 2.5 g/dL; Prothrombin time less than 1.6 For patients without prior pelvic radiotherapy: AST at least 3 times upper limit of normal (ULN) OR Bilirubin 1.0 - 7.0 mg/dL with any AST OR Creatinine 1.6 - 5.0 mg/dL; For patients with prior pelvic radiotherapy: AST less than 3 times ULN AND Bilirubin less than 1.0 mg/dL AND Creatinine less than 1.6 mg/dL - Other: Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlanVenook, Study Chair, Cancer and Leukemia Group B
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Additional Information:
Study ID Numbers: CDR0000066357; CLB-9863
Study Start Date: June 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003368
Other Leukemia Studies:
1. Stem Cell Transplantation in Treating Patients with Hematologic Cancer
2. Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia
3. Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
4. Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
5. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
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Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis
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