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Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants Clinical research trials and Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants. Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants  Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
For Condition: unspecified childhood solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants. II. Determine the dose-limiting toxicity of irinotecan in this patient population. III. Evaluate the pharmacokinetic behavior of this treatment regimen in these patients. IV. Determine, preliminarily, the antitumor activity of this treatment regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants). Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is reached. 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. Patients are followed every 6 months for up to 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed malignancy refractory to conventional therapy or for which no conventional therapy exists - Histologic confirmation not required for brain stem tumors Concurrently on anticonvulsants at a steady level for at least 2 weeks --Prior/Concurrent Therapy-- Biologic therapy: - At least 1 week since prior antineoplastic biologic therapy - At least 6 months since prior allogeneic stem cell transplantation - At least 1 week since prior growth factors - No concurrent sargramostim (GM-CSF) - No concurrent prophylactic growth factors during first course of study therapy - Recovered from prior immunotherapy Chemotherapy: At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered Endocrine therapy: Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed if dose stable or decreasing for at least 2 weeks prior to study Radiotherapy: - At least 2 weeks since prior local palliative radiotherapy (small part) - At least 6 months since prior craniospinal radiotherapy - At least 6 months since prior radiotherapy to at least 50% of pelvis - At least 6 weeks since prior substantial bone marrow radiotherapy - Recovered from prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agent --Patient Characteristics-- Age: At least 365 days and under 22 years Performance status: - Karnofsky 50-100% (over 10 years of age) - Lansky 50-100% (10 years of age or under) Life expectancy: At least 8 weeks Hematopoietic: - Neutrophil count at least 1,000/mm3 - Platelet count at least 100,000/mm3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed) Hepatic: - Bilirubin no greater than 1.5 times normal for age - SGPT less than 5 times normal for age - Albumin at least 2 g/dL Renal: - Creatinine no greater than 1.5 times normal for age OR - Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection - No evidence of active graft-vs-host disease - Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlbertMoghrabi, Study Chair, Children's Oncology Group
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Children's Hospital of Denver
Denver, Colorado, 80218
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Mott Children's Hospital
Ann Arbor, Michigan, 48109-7821
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Australia
CCOP - Green Bay
Green Bay, Wisconsin, 54301
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000068410; POG-P9871,COG-P9871
Study Start Date: October 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008424
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
2. Anidulafungin in Treating Immunocompromised Children With Neutropenia
3. Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
4. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
5. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other California Clinical Trials
Other Orange Clinical Trials
Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
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