Docetaxel in Treating Children With Recurrent Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS

Conditions
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Brain and Central Nervous System Tumors, Neuroblastoma, Sarcoma

Intervention / Treatment
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* Biological: filgrastim
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. | Biological: filgrastim<br> <br> Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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