Safety and Tolerability of Carboxyamidotriazole Orotate (CTO) in Solid Tumors or With Temodar® in Glioblastoma or Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas

Exclusion Criteria

• •1. Patients may not have had prior chemotherapy, hormonal therapy, radiation therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study.
• •2. Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:
• •* Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias.
• •* Active infection.
• •* Unstable diabetes mellitus
• •* Psychiatric disorder that may interfere with consent and/or protocol compliance.
• •3. Pregnant or breastfeeding women.
• •4. Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does not require further treatment.
• •5. Patients with known HIV, HBV, or HCV infection.
• •6. Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.
• •7. Patients with central nervous system metastases. Baseline CT or MRI scan of brain is required only in the case of clinical suspicion of central nervous system metastases. Patients with evidence of brain involvement, leptomeningeal disease, or seizure disorder are also excluded.
• •8. Patients may not be treated with known CYP3A4 inhibitors or inducers.
• •1. Patients may not have had prior chemotherapy, hormonal therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study. Additional exceptions: The following specific drugs are permitted shorter recovery times: 14 days for vincristine, 21 days for procarbazine, and 7 days for non-cytotoxic agents such as interferon, tamoxifen, thalidomide, and cis-retinoic acid.
• •2. Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:
• •* Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias.
• •* Active infection.
• •* Unstable diabetes mellitus.
• •* Psychiatric disorder that may interfere with consent and/or protocol compliance.
• •3. Pregnant or breastfeeding women.
• •4. Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does not require further treatment.
• •5. Patients with known HIV, HBV, or HCV infection.
• •6. Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.
• •7. Uncontrolled seizure activity.
• •8. Patients may not be treated with known CYP3A4 inhibitors or inducers.
• •2. Patients must have a life expectancy of at least 8 weeks
• •3. Patients must have a Performance Status of 0, 1, or 2 (ECOG scale).
• •4. Patients must be men and women \>=18 years of age.
• •5. Patients must have undergone an MRI scan performed within 14 days prior to registration and must be on a steroid dose that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required.
• •6. Patients under treatment with anti-epileptic drugs which are not known CYP3A4 inhibitors or inducers must have been receiving a stable dose for at least 2 weeks with no evidence of seizures at the time of registration.
• •1. Patients may not have had any prior chemotherapy, hormonal therapy, or biologic therapy for gliomas.
• •2. Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:
• •* Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias.
• •* Active infection.
• •* Unstable diabetes mellitus.
• •* Psychiatric disorder that may interfere with consent and/or protocol compliance.
• •3. Pregnant or breastfeeding women.
• •4. Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does not require further treatment.
• •5. Patients with known HIV, HBV, or HCV infection.
• •6. Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.
• •7. Uncontrolled seizure activity.
• •8. Patients may not be treated with known CYP3A4 inhibitors or inducers.
• •9. Patients with anaplastic oligodendroglioma with 1p/19q deletion or unknown 1p/19q status are excluded.