Completed

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

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What is being tested

filgrastim

+ docetaxel

BiologicalDrug
Who is being recruted

Glioma+19

+ Neoplasms

+ Neoplasms by Histologic Type

Until 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 1997
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002825
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

GliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Connective TissueNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialAstrocytomaMedulloblastomaNeuroblastomaSarcomaOsteosarcomaCentral Nervous System NeoplasmsNeuroectodermal Tumors, Primitive, Peripheral

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 36 locations

Long Beach Memorial Medical Center

Long Beach, United StatesOpen Long Beach Memorial Medical Center in Google Maps

Children's Hospital Los Angeles

Los Angeles, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United States

Children's Hospital of Orange County

Orange, United States
Completed36 Study Centers