Clinical Trial: Docetaxel in Treating Children With Recurrent Solid Tumors

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Children's Cancer Group
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
recurrent childhood brain stem glioma
recurrent childhood rhabdomyosarcoma
recurrent neuroblastoma
recurrent childhood ependymoma
recurrent childhood supratentorial primitive neuroectodermal and pineal tumors
recurrent childhood cerebral astrocytoma
recurrent childhood soft tissue sarcoma
recurrent osteosarcoma
recurrent childhood cerebellar astrocytoma
recurrent childhood medulloblastoma
recurrent tumors of the Ewing's family
 Drug: docetaxel
 Drug: filgrastim
Phase II

MedlinePlus related topics:  Bone Cancer;   Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Neuroblastoma;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Docetaxel in Children with Recurrent Sarcomas, Neuroblastomas, or Brain Tumors

Further Study Details: 

Study start: April 2001

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.

PROTOCOL 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

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--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

Location Information


California
      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States

      Children's Hospital of Orange County, Orange,  California,  92868,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      Kaiser Permanente Medical Center-Sacramento, Sacramento,  California,  95825,  United States

      Long Beach Memorial Medical Center, Long Beach,  California,  90806,  United States

      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States

Colorado
      Children's Hospital of Denver, Denver,  Colorado,  80218,  United States

District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States

Iowa
      Holden Comprehensive Cancer Center at The University of Iowa, Iowa City,  Iowa,  52242-1009,  United States

Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

Missouri
      Children's Mercy Hospital, Kansas City,  Missouri,  64108,  United States

Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States

New Jersey
      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States

Ohio
      Children's Hospital Medical Center - Cincinnati, Cincinnati,  Ohio,  45229-3039,  United States

      Children's Hospital of Columbus, Columbus,  Ohio,  43205-2696,  United States

      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Oregon
      Doernbecher Children's Hospital, Portland,  Oregon,  97201-3098,  United States

Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States

      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States

Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6838,  United States

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States

Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States

      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States

Australia, Western Australia
      Princess Margaret Hospital for Children, Perth,  Western Australia,  6001,  Australia

Canada, British Columbia
      British Columbia Children's Hospital, Vancouver,  British Columbia,  V6H 3V4,  Canada

Canada, Nova Scotia
      IWK Health Centre, Halifax,  Nova Scotia,  B3J 3G9,  Canada

Study chairs or principal investigators

Theodore Zwerdling,  Study Chair,  Children's Cancer Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

Blaney SM, Seibel NL, O'Brien M, Reaman GH, Berg SL, Adamson PC, Poplack DG, Krailo MD, Mosher R, Balis FM. Phase I trial of docetaxel administered as a 1-hour infusion in children with refractory solid tumors: a collaborative pediatric branch, National Cancer Institute and Children's Cancer Group trial. J Clin Oncol. 1997 Apr;15(4):1538-43.

Study ID Numbers:  CDR0000065008; CCG-0962
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002825
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005