A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven malignant recurrent or progressive brain
tumor at initial presentation or at time of recurrence or progression for which no
standard curative therapy exists Histologic verification for brainstem gliomas may be
waived Bone marrow involvement allowed

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Karnofsky 60-100% Life
expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count greater than
1,000/mm3* Platelet count greater than 75,000/mm3* Hemoglobin greater than 9 g/dL
*Transfusion independent Hepatic: Bilirubin normal for age SGOT and SGPT less than 2.5
times normal for age PT/PTT no greater than 1.2 times upper limit of normal Albumin
greater than 3 g/dL No overt hepatic disease Renal: Creatinine no greater than 1.5 times
normal for age OR Glomerular filtration rate greater than 70 mL/min No overt renal disease
Cardiovascular: No deep venous or arterial thrombosis within the past 3 months No history
of myocardial infarction, severe or unstable angina, or severe peripheral vascular disease
No overt cardiac disease No prior cerebral bleeds Pulmonary: No pulmonary embolism within
the past 3 months No overt pulmonary disease Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No known allergies to
paclitaxel or other agent that uses Cremophor EL No uncontrolled infection Neurological
deficits allowed if stable for at least 1 week prior to study Greater than 3rd percentile
weight for height

PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior bone marrow
transplantation More than 1 week since prior growth factor(s) Chemotherapy: At least 3
weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy: Concurrent dexamethasone allowed if dose stable for at least 1 week
prior to study Radiotherapy: More than 3 months since prior craniospinal irradiation
greater than 24 Gy More than 3 months since prior total body irradiation More than 2 weeks
since prior focal irradiation to symptomatic metastatic sites No prior stereotactic
radiosurgery Concurrent total body irradiation allowed Surgery: See Radiotherapy Other: No
other concurrent anticancer or experimental drug therapy Concurrent anticonvulsant drugs
allowed