Back to resultsDocetaxel in Treating Children With Recurrent Solid Tumors
Primary Purpose
Brain and Central Nervous System Tumors, Neuroblastoma, Sarcoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
filgrastim
docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent childhood rhabdomyosarcoma, recurrent neuroblastoma, recurrent osteosarcoma, recurrent childhood soft tissue sarcoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically verified (at original diagnosis) solid tumor that is relapsed or refractory The following histologies are eligible: Sarcomas: Rhabdomyosarcoma Ewing's sarcoma, Peripheral neuroectodermal tumor (PNET), Osteosarcoma, Other soft tissue sarcomas 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
Sites / Locations
- Long Beach Memorial Medical Center
- Children's Hospital Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Children's Hospital of Orange County
- Kaiser Permanente Medical Center-Sacramento
- UCSF Cancer Center and Cancer Research Institute
- Children's Hospital of Denver
- Children's National Medical Center
- University of Chicago Cancer Research Center
- Indiana University Cancer Center
- Holden Comprehensive Cancer Center at The University of Iowa
- University of Michigan Comprehensive Cancer Center
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- Children's Mercy Hospital
- University of Nebraska Medical Center
- St. Joseph's Hospital and Medical Center
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Herbert Irving Comprehensive Cancer Center
- Lineberger Comprehensive Cancer Center, UNC
- Children's Hospital Medical Center - Cincinnati
- Ireland Cancer Center
- Children's Hospital of Columbus
- Doernbecher Children's Hospital
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Vanderbilt-Ingram Cancer Center
- University of Texas - MD Anderson Cancer Center
- Huntsman Cancer Institute
- Children's Hospital and Regional Medical Center - Seattle
- Fred Hutchinson Cancer Research Center
- University of Wisconsin Comprehensive Cancer Center
- Princess Margaret Hospital for Children
- British Columbia Children's Hospital
- IWK Health Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm I
Arm Description
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002825
First Posted
November 1, 1999
Last Updated
February 4, 2013
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00002825
Brief Title
Docetaxel in Treating Children With Recurrent Solid Tumors
Official Title
A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description
OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Neuroblastoma, Sarcoma
Keywords
recurrent childhood rhabdomyosarcoma, recurrent neuroblastoma, recurrent osteosarcoma, recurrent childhood soft tissue sarcoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
docetaxel
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically verified (at original diagnosis) solid tumor that is relapsed or refractory The following histologies are eligible:
Sarcomas: Rhabdomyosarcoma Ewing's sarcoma, Peripheral neuroectodermal tumor (PNET), Osteosarcoma, Other soft tissue sarcomas
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Zwerdling, MD
Organizational Affiliation
University of California, Davis
Official's Role
Study Chair
Facility Information:
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Kaiser Permanente Medical Center-Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Children's Hospital of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Children's Hospital Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Children's Hospital of Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
9193350
Citation
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.
Results Reference
background
PubMed Identifier
16532433
Citation
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.
Results Reference
result
Learn more about this trial
Docetaxel in Treating Children With Recurrent Solid Tumors
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