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Docetaxel in Treating Children With Recurrent Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002825
First Posted: March 1, 2004
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Brain and Central Nervous System Tumors Neuroblastoma Sarcoma Biological: filgrastim Drug: docetaxel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 20
Study Start Date: January 1997
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.
Biological: filgrastim Drug: docetaxel

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002825


  Show 36 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Theodore Zwerdling, MD University of California, Davis
  More Information

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002825     History of Changes
Other Study ID Numbers: NCI-2012-02247
CCG-0962
CDR0000065008 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: November 1, 1999
First Posted: March 1, 2004
Last Update Posted: February 5, 2013
Last Verified: May 2006

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Sarcoma
Neuroblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action