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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | January 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00002825 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Docetaxel in Treating Children With Recurrent Solid Tumors | ||||
| Official Title ICMJE | A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS | ||||
| Brief Summary | 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. |
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| 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. 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002825 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065008, CCG-0962 | ||||
| Study Sponsor ICMJE | Children's Cancer Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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