Methotrexate, Trimetrexate Glucuronate, and Leucovorin in Treating Patients With Refractory or Recurrent Osteosarcoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed malignant osteosarcoma
• •* High-grade disease
• •Recurrent or refractory disease after prior standard chemotherapy comprising methotrexate, doxorubicin, cisplatin, and ifosfamide
• •No low-grade osteosarcoma
• •No parosteal or periosteal sarcoma
• •No osteosarcoma arising in premalignant bony lesions (e.g., Paget's disease) OR in a prior radiotherapy field
• •No symptomatic or known brain or leptomeningeal involvement
• •PATIENT CHARACTERISTICS:
• •Age
• •1 to 35
• •Performance status
• •Karnofsky 70-100% (for patients \> 16 years of age)
• •Lansky 70-100% (for patients ≤ 16 years of age)
• •Life expectancy
• •At least 3 months
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,000/mm\^3
• •Platelet count ≥ 75,000/mm\^3
• •Hepatic
• •Bilirubin ≤ 1.5 times normal
• •AST and ALT ≤ 5 times normal
• •Albumin ≥ 2 g/dL
• •No clinically significant liver disease
• •Renal
• •Creatinine ≤ 1.5 times normal OR
• •Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal
• •Cardiovascular
• •Shortening fraction ≥ 27% by echocardiogram OR
• •Ejection fraction ≥ 50% by gated radionuclide study
• •No congestive heart failure
• •No angina pectoris
• •No myocardial infarction within the past year
• •No uncontrolled arterial hypertension
• •No uncontrolled arrhythmias
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No history of significant neurological or psychiatric disorder
• •No active infection
• •No symptomatic peripheral neuropathy ≥ grade 2
• •No other serious illness or medical condition
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •At least 7 days since prior biologic therapy
• •At least 6 months since prior allogeneic stem cell transplantation AND no evidence of active graft-versus-host disease
• •No concurrent sargramostim (GM-CSF)
• •Chemotherapy
• •See Disease Characteristics
• •More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •At least 2 weeks since prior local palliative radiotherapy (small port)
• •At least 6 months since prior craniospinal radiotherapy
• •At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
• •At least 6 weeks since prior substantial radiotherapy to the bone marrow
• •Surgery
• •Not specified
• •Other
• •Recovered from prior therapy
• •More than 30 days since prior and no other concurrent investigational drugs
• •More than 30 days since prior and no concurrent participation in another clinical trial
• •No concurrent medications that may interact with study drugs