A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma

Inclusion Criteria

• •Must have been diagnosed with osteosarcoma by the age of 25 years.
• •Patient must have a biopsy proven osteosarcoma and either: a) active tumor with no available standard therapy options; b) metastatic osteosarcoma at diagnosis, has completed therapy and has no evidence of active disease; or, c) is status-post any surgery for recurrent osteosarcoma, either local or metastatic recurrence, and is free of disease by CT scan.
• •Measurable disease not required.
• •Patients with serum creatinine \&lte; 2.0 mg/dL or creatinine clearance \&gte; 40 ml/min per 1.73m(2) (if serum creatinine is \&gte; 2.0 mg/dL).
• •Patients with normal thyroid function.
• •Patients with total bilirubin, SGOT and SGPT \< twice the upper limit of normal.
• •Patients with normal direct bilirubin only if total direct bilirubin is abnormal.
• •Patients with bone marrow criteria: ANC\>1500/mm(3) and platelet count \>100,000/mm(3).
• •Patients without a history of insulin-dependent diabetes mellitus or current insulin requirement. Fasting morning blood glucose \<150 mg/dL.
• •Patients with ECOG performance status of 0, 1 or 2 and a life expectancy of at least 8 weeks.
• •Patients not on chemotherapy or radiation therapy within the past 2 weeks and recovered from the acute side effects of prior anti-neoplastic therapy.
• •Patients with documented negative HIV serology within the past 6 months.
• •Post-menarcheal patients must have documented negative urine and serum pregnancy test (B-HCG); when indicated, patient must be willing to take oral contraceptives or other appropriate contraceptives to avoid pregnancy during the period of treatment.
• •Patient, parent or guardian must give informed consent.
• •No pregnant or lactating women.
• •No women of child-bearing potential who are unable or unwilling to use appropriate contraceptives during the period of treatment.
• •No patients with uncorrected hypothyroidism.
• •No patients with insulin-dependent diabetes mellitus or fasting blood glucose \&gte; 150 mg/dL.
• •No patients with HIV infection.
• •No patients with a history of thromboembolic events who require prophylaxis for thromboembolic events with anticoagulants once entry into Cohort III has begun.
• •Patients with a history of symptomatic gallbladder disease must have had a cholecystectomy.