Docetaxel in Treating Children With Recurrent Solid Tumors
NCT ID: NCT00002825
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
1997-01-31
Brief Summary
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Detailed Description
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I. Determine the response rate to docetaxel in children with recurrent sarcomas, neuroblastomas, or brain tumors.
II. Describe the toxic effects of docetaxel in these patients.
OUTLINE:
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. Patients are followed for survival.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.
filgrastim
docetaxel
Interventions
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filgrastim
docetaxel
Eligibility Criteria
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Inclusion Criteria
* Brain tumors: Ependymoma Primitive neuroectodermal tumor (PNET), High grade astrocytoma, Brain stem glioma (histologic verification not required), Neuroblastoma
* Measurable disease that can be followed clinically or radiologically required
* The following not considered measurable: Bone lesions measured by bone scan or bone marrow involvement
* Central nervous system disease documented by cerebrospinal fluid cytology
* Pleural effusion
PATIENT CHARACTERISTICS:
* Age: 21 and under at original diagnosis
* Performance status: 0-3
* Life expectancy: Greater than 2 months
* In the absence of marrow involvement:
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 100,000/mm3 (transfusion independent)
* Hemoglobin at least 9.0 g/dL (transfusion allowed)
* With bone marrow involvement:
* Absolute neutrophil count at least 750/mm3
* Red cell and platelet support possible
* Bilirubin normal
* ALT/AST less than 1.5 times normal
* Alkaline phosphatase less than 2.5 times normal
* Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min
* Not pregnant or nursing
* Adequate contraception required of fertile women
PRIOR CONCURRENT THERAPY:
* Prior bone marrow transplantation allowed:
* Must have stable engraftment without need for significant blood product support or cytokine therapy
* No concurrent immunomodulating agents
* No prior paclitaxel or docetaxel At least 2 weeks since chemotherapy (4 weeks since nitrosoureas)
* No other concurrent cancer chemotherapy
* Concurrent corticosteroids allowed for intracranial pressure in brain tumor patients provided patient has been stable for at least 4 weeks
* Corticosteroids allowed as pretreatment for docetaxel
* At least 2 months since extensive radiotherapy, defined as:
* Craniospinal Volume greater than 50% of abdominopelvic cavity
* Volume greater than one third of lung volume
* No concurrent radiotherapy
* No more than 2 prior therapies and fully recovered
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Theodore Zwerdling, MD
Role: STUDY_CHAIR
University of California, Davis
Locations
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Long Beach Memorial Medical Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Kaiser Permanente Medical Center-Sacramento
Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Countries
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References
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Blaney SM, Seibel NL, O'Brien M, Reaman GH, Berg SL, Adamson PC, Poplack DG, Krailo MD, Mosher R, Balis FM. Phase I trial of docetaxel administered as a 1-hour infusion in children with refractory solid tumors: a collaborative pediatric branch, National Cancer Institute and Children's Cancer Group trial. J Clin Oncol. 1997 Apr;15(4):1538-43. doi: 10.1200/JCO.1997.15.4.1538.
Zwerdling T, Krailo M, Monteleone P, Byrd R, Sato J, Dunaway R, Seibel N, Chen Z, Strain J, Reaman G; Children's Oncology Group. Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors: a report from the Children's Oncology Group. Cancer. 2006 Apr 15;106(8):1821-8. doi: 10.1002/cncr.21779.
Other Identifiers
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CCG-0962
Identifier Type: -
Identifier Source: secondary_id
CDR0000065008
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02247
Identifier Type: -
Identifier Source: org_study_id
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