A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically proven primary CNS malignancy, neuroblastoma or sarcoma that is refractory to standard therapy or for which no standard therapy exists and disease can not be cured by surgery.
• •PRIOR/CONCURRENT THERAPY:
• •Recovered from toxic affects of all prior therapy.
• •No investigational agent within past 2 weeks.
• •BIOLOGY THERAPY: Not specified.
• •CHEMOTHERAPY:
• •No myelosuppressive therapy within past 3 weeks.
• •No nitrosourea within past 6 weeks.
• •ENDOCRINE THERAPY: If receiving dexamethasone dose must be stable for at least 2 weeks.
• •RADIOTHERAPY: Not specified.
• •SURGERY: Not specified.
• •PATIENT CHARACTERISTICS:
• •Age: 3 to 21.
• •Performance status: ECOG 0-2.
• •Life expectancy: At least 8 weeks.
• •HEMATOPOIETIC:
• •AGC greater than 1500/mm(3).
• •Hemoglobin greater than or equal to 8.0 g/dL percent.
• •Platelet count greater than 100,000/mm(3).
• •For patients with bone marrow involvement or history of bone marrow transplantation or craniospinal radiotherapy: AGC greater than 750/mm(3), Hemoglobin greater than 6.0 g/dL, Platelet count greater than 50,000/mm(3).
• •HEPATIC:
• •SGOT, SGPT or alkaline phosphatase less than 3 times upper limit of normal.
• •Bilirubin no less than or equal to 1.5 times upper limit of normal.
• •RENAL:
• •Ages 3-5 Creatinine no greater than 0.8 mg/dL.
• •Ages 5-10 Creatinine no greater than 1.0 mg/dL.
• •Ages 10-15 Creatinine no greater than 1.2 mg/dL.
• •Ages 16-21 Creatinine no greater than 1.5 mg/dL.
• •OTHER:
• •All patients or their legal guardians (if the patient is under 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study.
• •For patients with brain tumors who are over 18 years of age, a DPA should be signed.
• •Not pregnant or nursing.
• •Not allergic to etoposide.
• •No acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results.