A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed brain tumor including but not limited to the following: Anaplastic astrocytoma, Glioblastoma multiforme, Low-grade glioma, Ependymoma, Medulloblastoma, Pineal tumors, Chiasmal glioma, Craniopharyngioma, Brain stem glioma (requirement for histologic diagnosis may be waived).
• Disease refractory to standard therapy or no standard chemotherapy exists and ineligible for potential curative surgery or radiotherapy.
• Measurable or evaluable disease on radiographic studies with evidence of progression on prior chemotherapy or radiotherapy or persistent disease after surgery.
• PRIOR/CURRENT THERAPY:
• See Disease Characteristics
• At least 6 months since carboplatin.
• At least 3 weeks since myelosuppressive therapy.
• Patients who received stem cell or bone marrow rescue after nitrosourea therapy are eligible after 3 weeks if they have recovered from hematologic toxicities of their prior therapy.
• Concurrent steroids allowed if dose stable for at least 2 weeks prior to entry.
• Recovered from toxic effects of any prior therapy.
• PATIENT CHARACTERISTICS:
• Age: 21 and under.
• Performance status: ECOG 0-2.
• Life expectancy: At least 8 weeks.
• HEMATOLOGIC:
• Absolute granulocyte count greater than 1,500/mm(3).
• Platelet count greater than 100,000/mm(3) (at least 75,000/mm(3) in patients with prior bone marrow transplantation or craniospinal irradiation).
• Hemoglobin greater than 8.0 g/dL.
• HEPATIC:
• Bilirubin no greater than 2 times normal.
• ALT no greater than 2 times normal.
• RENAL:
• Creatinine within normal limits for age as follows:
• Age (in years) -- Creatinine (in mg/dL):
• Younger than 5 -- no greater than 1.2;
• 5-10 -- no greater than 1.5;
• 10-15 -- no greater than 1.8;
• Older than 15 -- no greater than 2.4.
• OTHER:
• No significant systemic illness.
• No pregnant or nursing women.
• Negative pregnancy test required of fertile women.
• Effective contraception required of fertile patients.
• Durable power of attorney required of all patients 18-21 years of age.