Methoxyamine and Temozolomide in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •Patients must have a histologically confirmed solid tumor that is considered incurable and is not amenable to conventional surgical, radiation therapy or chemotherapy treatment programs.
• •Prior chemotherapy and/or radiation are allowed. At least 3 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for mitomycin-C and nitrosoureas); and recovered from all treatment related toxicity to \< grade 1 according to NCI CTCAE version 3.0 (with the exception of alopecia and radiation-induced taste changes). Prior temozolomide treatment is not restricted.
• •ECOG performance status (PS) 0-2 (Karnofsky PS 50-100%)
• •Life expectancy ≥ 12 weeks
• •Patients must have normal organ and marrow function as defined below:
• •* Absolute neutrophil count ≥ 1,500/μL
• •* Platelet count ≥ 100,000/μL
• •* Hemoglobin ≥ 10.0 g/dL
• •* Total bilirubin ≤ 1.5 mg/dL
• •* AST ≤ 2.5 times upper limit of normal
• •* Creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 60 mL/min
• •Patients with known primary or metastatic CNS disease, are eligible for participation in cohort B, but not in cohort A.
• •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •Ability to understand and the willingness to sign a written informed consent document.