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.

Exclusion Criteria:

* Patients may not be receiving any other investigational agents or have received other investigational agents for at least 3 weeks.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and lactating women are excluded from this study because the methoxyamine and temozolomide combination is likely to be teratogenic.
* NYHA classification III or IV heart disease
* Patients with known primary or metastatic CNS disease (cohort B) are not eligible if they have a mini mental status exam score \< 15 or evidence of leptomeningeal disease.
* Patients with pre-existing neurologic toxicity \> grade1 (as per CTCAE, version 3.0) are not eligible for participation in cohort A.
* Patients screened for participation in cohort B with pre-existing neurologic toxicity \> grade 2 (as per CTCAE, version 3.0) are not eligible, unless pre-existing neurologic toxicity is documented in detail and patient's participation in the trial has been approved by the neuro-oncology team at participating institutions.