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Docetaxel in Treating Children With Recurrent Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00002825   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
January 1997
 
 
 
Complete list of historical versions of study NCT00002825 on ClinicalTrials.gov Archive Site
 
 
 
Docetaxel in Treating Children With Recurrent Solid Tumors
A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors.

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.

PROJECTED ACCRUAL: A total of 20 patients per disease category (soft tissue sarcomas, osteosarcoma, neuroblastoma, medulloblastoma/PNET, and astrocytoma/glioma) will be accrued for this study over 2-3 years. If no responses are seen in the first 10 patients within a category, accrual in that category will end.

Phase II
Interventional
Treatment
  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • Sarcoma
  • Biological: filgrastim
  • Drug: docetaxel
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
20
 
 

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 Hematopoietic: 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 Hepatic: Bilirubin normal ALT/AST less than 1.5 times normal Alkaline phosphatase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min Other: Not pregnant or nursing Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior bone marrow transplantation allowed: Must have stable engraftment without need for significant blood product support or cytokine therapy No concurrent immunomodulating agents Chemotherapy: No prior paclitaxel or docetaxel At least 2 weeks since chemotherapy (4 weeks since nitrosoureas) No other concurrent cancer chemotherapy Endocrine therapy: 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 Radiotherapy: 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 Surgery: Not specified Other: No more than 2 prior therapies and fully recovered

Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00002825
 
CDR0000065008, CCG-0962
Children's Cancer Group
National Cancer Institute (NCI)
Study Chair: Theodore Zwerdling, MD University of California, Davis
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP