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

Inclusion Criteria

• •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.