Docetaxel in Treating Children With Recurrent Solid Tumors

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Sarcoma

Neuroblastoma

Brain and Central Nervous System Tumors

Treatments

Drug: docetaxel

Biological: filgrastim

Study type

Interventional

Funder types

NIH

Identifiers

NCT00002825

NCI-2012-02247

CDR0000065008 (Registry Identifier)

CCG-0962

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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