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Docetaxel in Treating Children With Recurrent Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002825
First received: November 1, 1999
Last updated: February 4, 2013
Last verified: May 2006
History of Changes
  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: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002825

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002825     History of Changes
Other Study ID Numbers: NCI-2012-02247, CCG-0962, CDR0000065008
Study First Received: November 1, 1999
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

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:
Nervous System Neoplasms
Neuroblastoma
Central Nervous System Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Docetaxel
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013