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

Further Study Details: 

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.

Ages Eligible for Study:  up to  21 Years

Criteria

PROTOCOL ENTRY 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

--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

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   

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