RNR Inhibitor COH29 in Treating Patients with Metastatic, Progressive, or Recurrent Solid Tumors That Are Refractory to Standard Therapy, for Which No Standard Therapy Exists, or That Cannot Be Removed by Surgery

Inclusion Criteria

• All patients must have the ability to understand and the willingness to sign a written informed consent
• Age >= 18 years. Because no dosing or adverse event data are currently available on the use of COH29 in patients < 18 years of age, children are excluded from this study
• Life expectancy of greater than 3 months by physician assessment
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) solid tumor that is metastatic, unresectable, progressive, or recurrent, and for which standard curative or palliative measures do not exist or are no longer effective
• Patients must have measurable or evaluable disease
• Patients must not have received prior chemotherapy or radiation for < 4 weeks prior to start of study treatment
• Patients may be entered if they have received prior radiation therapy involving =< 30% of the bone marrow; any prior radiation therapy must have been administered >= 4 weeks prior to start of study treatment and the patient must be recovered from the acute toxic effects of the treatment prior to start of study treatment
• Patients may be enrolled with a history of treated brain metastases that are clinically stable for >= 4 weeks prior to start of study treatment
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; a female of child-bearing potential is defined as a sexually active mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally menopausal for at least 24 consecutive months; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
• No active breast-feeding, as the safety of COH29 is unknown for women who are breast-feeding, active breast-feeding is also not allowed on study enrollment
• Leukocytes >= 3,000 cells/uL (to be performed within 7 days prior to start of study treatment)
• Absolute neutrophil count >= 1,500 cells/uL (to be performed within 7 days prior to start of study treatment)
• Platelets >= 100,000 cells/uL (to be performed within 7 days prior to start of study treatment)
• Total bilirubin =< 1.5 times the upper limit of normal (ULN) (to be performed within 7 days prior to start of study treatment)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN; AST/ALT =< 5 x ULN if liver metastasis is present (to be performed within 7 days prior to start of study treatment)
• Serum creatinine =< 1.5 mg/dL or a measured creatinine clearance >= 50 mL/min (to be performed within 7 days prior to start of study treatment)
• Prothrombin time (PT)/international normalized ratio (INR)/ activated partial thromboplastin time (aPTT) =< 1.5 x ULN (to be performed within 7 days prior to start of study treatment)
• Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) (to be performed within 7 days prior to start of study treatment)

Exclusion Criteria

• Patients may not be receiving any other investigational agents; use of over-the-counter herbal medications will also be excluded
• Patients with uncontrolled undercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients unable or unwilling to swallow pills
• Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease or heart block, or uncontrolled congestive heart failure
• Patients with a history of noninfectious pneumonitis will be excluded during the dose-escalation phase of the trial
• Patients, who in the opinion of the investigator and another independent party, may not be able to adhere to the safety monitoring requirements of the study