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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002825

  Hide Study Locations
Locations
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital of Orange County
Orange, California, United States, 92868
Kaiser Permanente Medical Center-Sacramento
Sacramento, California, United States, 95825
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Colorado
Children's Hospital of Denver
Denver, Colorado, United States, 80218
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, New Jersey
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Children's Hospital of Columbus
Columbus, Ohio, United States, 43205-2696
United States, Oregon
Doernbecher Children's Hospital
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Sponsors and Collaborators
Investigators
Study Chair: Theodore Zwerdling, MD University of California, Davis
  More Information

Additional 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
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014