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A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS


Phase 2
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Neuroblastoma, Sarcoma

Thank you

Trial Information

A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Theodore Zwerdling, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02247

NCT ID:

NCT00002825

Start Date:

January 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • Sarcoma
  • 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
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Kaiser Permanente Medical Center-SacramentoSacramento, California  95825