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| Sponsors and Collaborators: |
Children's Cancer Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002825 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neuroblastoma Sarcoma |
Biological: filgrastim Drug: docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 1997 |
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 36 Study Locations| Study Chair: | Theodore Zwerdling, MD | University of California, Davis |
More Information
| Study ID Numbers: | CDR0000065008, CCG-0962 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002825 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Neuroectodermal Tumors, Primitive Central Nervous System Neoplasms Ependymoma Neuroblastoma Docetaxel Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Soft Tissue Sarcomas Neoplasms, Germ Cell and Embryonal Neuroepithelioma Osteogenic Sarcoma Glioma Ewing's Family of Tumors Nervous System Neoplasms |
Rhabdomyosarcoma Astrocytoma Osteosarcoma Rhabdomyosarcoma, Childhood Ewing's Sarcoma Recurrence Neuroectodermal Tumors Brain Stem Glioma, Childhood Malignant Mesenchymal Tumor Medulloblastoma Sarcoma Peripheral Neuroectodermal Tumor Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
|
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Pharmacologic Actions Neuroblastoma Docetaxel Neoplasms, Connective and Soft Tissue |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Sarcoma Neoplasms, Neuroepithelial Nervous System Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
