Phase I Trial and Pharmacokinetic Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, on a 7 Day and 21 Day Dosing Schedule in Pediatric Patients With Refractory Solid Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor*, including, but not limited to, the following:

- Rhabdomyosarcoma

- Other soft tissue sarcomas

- Ewing's sarcoma family of tumors

- Osteosarcoma

- Neuroblastoma

- Wilms' tumor

- Hepatic tumors

- Germ cell tumors

- Primary brain tumors

- Brain stem or optic gliomas (histological confirmation may be waived if a biopsy
has not been performed) NOTE: *Closed to accrual for all diagnoses except
neuroblastoma as of 4/16/05

- Relapsed after or failed to respond to frontline standard therapy and no other
standard treatment options (e.g., surgery, radiotherapy, chemotherapy, or any
combination of these modalities) exist

- Measurable or evaluable disease* NOTE: *Not required for patients with neuroblastoma

- No CNS tumor with motor or sensory deficits that would obscure the study assessment
of sensory neuropathy

PATIENT CHARACTERISTICS:

Age:

- 18 and under

Performance status:

- Lansky 60-100% (age 10 and under)

- Karnofsky 60-100% (age 11 to 18)

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT and AST no greater than 2.5 times ULN (5 times ULN for patients treated after the
maximum tolerated dose is determined)

- No clinically significant hepatic dysfunction

Renal:

- Creatinine normal for age OR

- Creatinine clearance at least 60 mL/min

- No clinically significant renal dysfunction

Cardiovascular:

- LVEF normal by echocardiogram

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No allergy to sulfa-containing medications

- No clinically significant unrelated systemic illness (e.g., other organ dysfunction)
that would preclude study participation

- No serious infection

- No preexisting grade 2 or greater sensory or motor neuropathy

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 months since prior bone marrow transplantation

- At least 72 hours since prior interleukin-11

- At least 72 hours since prior colony-stimulating factors (e.g., filgrastim [G-CSF] or
sargramostim [GM-CSF]) except epoetin alfa

- No concurrent growth factors (e.g., GM-CSF) except epoetin alfa

- Concurrent G-CSF allowed if neutropenia lasts longer than 5 days OR if the
patient experiences confirmed septicemia associated with neutropenia

- No concurrent immunotherapy

- No concurrent interleukin-11

Chemotherapy:

- See Disease Characteristics

- At least 30 days since prior chemotherapy (42 days for nitrosoureas)

- No other concurrent anticancer chemotherapy

Endocrine therapy:

- Patients with brain tumors:

- Must be on a stable or tapering dose of corticosteroids for 7 days before
baseline scan performed for the purpose of assessing response to study therapy

- Concurrent corticosteroids allowed for control of symptoms of tumor-associated
edema

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- At least 4 months since prior extensive radiotherapy (craniospinal radiotherapy,
total body irradiation, or radiotherapy to more than 50% of the pelvis)

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- Recovered from prior therapy

- At least 30 days since prior investigational anticancer therapy

- No other concurrent investigational agents