Gefitinib in Treating Children With Refractory Solid Tumors

Inclusion Criteria:

• Histologically confirmed solid tumor at original diagnosis
• Refractory to conventional therapy and other therapies of higher priority according to the COG Phase I/II priority list or no conventional therapy exists
• No primary CNS tumors or known metastases to the CNS
• Performance status - Karnofsky 50-100% (over 10 years of age)
• Performance status - Lansky 50-100% (10 years of age and under)
• At least 8 weeks
• Absolute neutrophil count at least 1,000/mm^3
• Platelet count at least 50,000/mm^3 (transfusion independent)
• Hemoglobin at least 8.0 g/dL (RBC transfusion allowed)
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT no greater than 3 times ULN
• Albumin at least 2 g/dL
• Creatinine normal for age
• Glomerular filtration rate at least 70 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection

• At least 6 months since prior allogeneic stem cell transplantation (SCT)

  • No evidence of active graft-versus-host disease
• At least 1 week since prior biologic agents
• At least 1 week since prior hematopoietic growth factors
• Recovered from prior immunotherapy
• At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
• No concurrent tamoxifen
• At least 2 weeks since prior local palliative (small port) radiotherapy
• At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis (6 weeks for radiotherapy to other substantial amount of bone marrow)
• Recovered from prior radiotherapy
• No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, Amiodarone, or chloroquine)
• No concurrent enzyme-activating anticonvulsants
• No concurrent proton pump inhibitors or H-2 blockers within 4 hours of gefitinib administration