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Ecteinascidin 743 in Treating Children With Refractory Solid Tumors Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Ecteinascidin 743 in Treating Children With Refractory Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Ecteinascidin 743 in Treating Children With Refractory Solid Tumors Clinical research trials and Ecteinascidin 743 in Treating Children With Refractory Solid Tumors healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Ecteinascidin 743 in Treating Children With Refractory Solid Tumors. Ecteinascidin 743 in Treating Children With Refractory Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Ecteinascidin 743 in Treating Children With Refractory Solid Tumors clinical trial. Participants typically obtain the most effective healthcare available for their Ecteinascidin 743 in Treating Children With Refractory Solid Tumors condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Ecteinascidin 743 in Treating Children With Refractory Solid Tumors  Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
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. Ecteinascidin 743 may be an effective treatment for solid tumors. PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 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. PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/17 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignant solid tumor at original diagnosis - Refractory to standard treatment or no curative therapy available - No CNS tumor - No bone marrow metastases (for less heavily pretreated stratum only) --Prior/Concurrent Therapy-- - Biologic therapy: At least 1 week since prior biologic therapy and recovered; At least 1 week since prior growth factor therapy; At least 6 months since prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease; For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation - Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered; No prior ecteinascidin 743; For less heavily pretreated stratum: No more than 2 prior chemotherapy regimens - Endocrine therapy: Not specified - Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port); At least 6 weeks since prior substantial bone marrow radiotherapy; At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis; For less heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater; No prior irradiation to greater than 50% of pelvis; Recovered from toxic effects of prior radiotherapy - Surgery: Not specified - Other: No concurrent foods or medication that interferes with P-450 metabolism; Anticonvulsants allowed --Patient Characteristics-- - Age: At least 365 days to 17 years - Performance status: Karnofsky 50-100% (for patients older than 10 years); Lansky 50-100% (for patients 10 years and younger) - Life expectancy: At least 8 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 (transfusion independent); Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) - Hepatic: Bilirubin no greater than normal; SGPT no greater than 2.5 times normal Albumin at least 2 g/dL; Alkaline phosphatase normal; Gamma glutamyl transferase less than 2.5 times normal - Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR at least lower limit of normal - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Creatine phosphokinase less than 2 times normal; No uncontrolled infection; Seizure disorder allowed if well controlled on anticonvulsants; No CNS toxicity greater than grade II
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SylvainBaruchel, Study Chair, Children's Oncology Group
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
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
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
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
Additional Information:
Study ID Numbers: CDR0000068273; COG-P9972,POG-P9972
Study Start Date: October 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006463
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
2. Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
3. Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
4. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
5. Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Related Studies:
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Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
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