NCT Number: NCT00002825
Docetaxel in Treating Children With Recurrent Solid Tumors
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.
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Conditions
Age range
Up to 21 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
docetaxel
DrugSponsors and collaborators
Lead sponsor
National Cancer Institute (NCI)
Nih
Registry information
Official study title
A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS
Important dates
- Study start
- 1997
- Primary completion
- 2004
- First posted
- Mar 1, 2004
- Registry last updated
- Feb 5, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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