Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Oklahoma
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients have newly diagnosed histologically proven WHO grade III or grade IV Glioblastoma Multiforme (GBM).
Patients at initial presentation of GBM must undergo an adequate surgical resection of the primary lesion; patients must be registered within 49 days (7 weeks) of the surgery.
Patients must have available and be willing to submit a minimum of five unstained slides tumor tissue specimens from the GBM surgery or open biopsy for MGMT status analysis and molecular profile analysis.
ECOG performance status within 0 - 2
Full recovery (\< grade 1) from the adverse events associated with prior surgery or any earlier intervention and a minimum of 28 days from the administration of any investigational agent
Adequate renal, liver and bone marrow function: Leukocytes \>3,000/mcL; Absolute neutrophil count \>1,500/mcL; Platelets \>100,000/mcL; AST / ALT (SGPT) \<2.5 x ULN; Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL); Creatinine within normal limits
Patients must be ≥ 18 years of age
Patients must be willing to have blood draws for PK analysis
All patients must have a CT or MRI of the brain within 14 days prior to registration. The brain CT or MRI should be performed with intravenous contrast (unless contraindicated).
Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and progression-free survival evaluation;
Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
Male patient agrees to use an adequate method of contraception
Birth control should be used from the signing of the patient consent form and for 120 days following the last dose of study treatment.
In addition, men must not donate sperm during study therapy and for 120 days after receiving the last dose of study treatment.
You may not be if
Second primary malignancy (except adequately treated basal cell carcinoma of the skin).
Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligible
Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
Patients with moderate or severe renal impairment (calculated creatinine clearance of \< 60 mL/min)
Patients with sodium, potassium, or creatinine serum electrolytes \> grade 2.
Screening ECG abnormality documented by the investigator as medically significant
Inability to comply with protocol or study procedures.
