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Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas Clinical research trials and Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas. Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas clinical trial. Participants frequently obtain the most expert healthcare available for their Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas  Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
For Condition: childhood bone cancer,childhood soft tissue sarcoma,childhood brain cancer,childhood kidney tumors,childhood non-Hodgkin's lymphoma,childhood eye cancer
Status: No longer recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
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 flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas. - Determine the toxic effects and pharmacokinetics of this drug in these patients. - Determine the antitumor activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of flavopiridol 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 toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed relapsed or refractory solid tumor or lymphoma including: - Neuroblastoma - Osteosarcoma - Ewing's sarcoma - Rhabdomyosarcoma - Wilms tumor - CNS tumors - Histological verification not required for brainstem tumors - No acute leukemia - Not eligible for higher priority COG phase I/II study PATIENT CHARACTERISTICS: Age: - Under 22 Performance status: - Karnofsky 50-100% (over age 10) - Lansky 50-100% (age 10 and under) Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (transfusion allowed) - No granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow involvement Hepatic: - Bilirubin no greater than 1.5 times normal - SGPT no greater than 5 times normal - Albumin at least 2 g/dL Renal: - Creatinine no greater than 1.5 times normal OR - Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal Cardiovascular: - Shortening fraction at least 27% by echocardiogram OR - Ejection fraction at least 50% by MUGA Other: - Stable neurologic deficits within the past 2 weeks for patients with CNS tumors - CNS toxicity less than grade 2 - No active graft-versus-host disease - No active uncontrolled infection or other serious medical condition - No uncontrolled diabetes mellitus - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 7 days since prior biologic therapy and recovered - Prior bone marrow or stem cell transplantation allowed - At least 6 months since prior allogeneic stem cell transplantation - At least 1 week since prior growth factors - No concurrent immunomodulating agents Chemotherapy: - At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered - No other concurrent chemotherapy Endocrine therapy: - Concurrent dexamethasone for CNS tumors allowed if on stable dose for at least 2 weeks prior to study - Concurrent corticosteroids allowed only for increased intracranial pressure in patients with CNS tumors Radiotherapy: - At least 2 weeks since prior local (small port) palliative radiotherapy - At least 6 months since prior radiotherapy to 50% or more of the pelvis - At least 6 months since prior craniospinal radiotherapy - At least 6 weeks since other prior substantial bone marrow radiotherapy - Recovered from prior radiotherapy - No concurrent radiotherapy except localized palliative radiotherapy Surgery: - Not specified Other: - No concurrent anticonvulsants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesWhitlock, Study Chair, Vanderbilt-Ingram Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Jonathan Jaques Children's Cancer Center
Long Beach, California, 90801-1428
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Hospital of Denver
Denver, Colorado, 80218-1088
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Mott Children's Hospital
Ann Arbor, Michigan, 48109-0914
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021-4885
United States
Floating Hospital for Children
Boston, Massachusetts, 02111
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Australia
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0361
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Additional Information:
Study ID Numbers: CDR0000068491; COG-ADVL0017,NCI-A0972,CCG-AO972
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012181
Other Childhood Bone Cancer Studies:
1. Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
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Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
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