Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or progressive (refractory) brain tumors

- Histologic confirmation waived for brainstem gliomas

- Bone marrow involvement allowed if transfusion independent

PATIENT CHARACTERISTICS:

Age:

- 21 and under

Performance status:

- Lansky 60-100% OR

- Karnofsky 60-100%

Life expectancy:

- More than 8 weeks

Hematopoietic:

- See Disease Characteristics

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 75,000/mm^3

- Hemoglobin greater than 9 g/dL

Hepatic:

- Bilirubin no greater than upper limit of normal

- SGPT and SGOT less than 2.5 times normal

- Albumin greater than 3 g/dL

- PT/PTT no greater than 120% upper limit of normal

- No overt hepatic disease

Renal:

- Creatinine no greater than 1.5 times normal OR

- Glomerular filtration rate greater than 70 mL/min

- No overt renal disease

Cardiovascular:

- No overt cardiac disease

Pulmonary:

- No overt pulmonary disease

Other:

- Neurologic deficits allowed if stable for at least 1 week prior to study

- More than 3rd percentile weight for height

- Able to swallow pills

- No uncontrolled infection

- No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon
dioxide, or magnesium stearate I

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 10 weeks after
study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- More than 6 months since prior bone marrow transplantation

- More than 1 week since prior growth factors

Chemotherapy:

- At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
and recovered

Endocrine therapy:

- Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study

- Concurrent oral contraceptives or other hormonal contraceptive methods allowed

Radiotherapy:

- More than 6 weeks since prior substantial bone marrow radiotherapy

- More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total
body irradiation

- More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites

Surgery:

- Not specified

Other:

- No concurrent enzyme-inducing anticonvulsant drugs

- No other concurrent anticancer or experimental drug therapy