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

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