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|NCT02186509 : Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas|
|Ages||Min: 18 Years Max: N/A|
1. Patients must have a previously histologically or cytologically confirmed high grade
glioma (astrocytic or oligodendroglial supratentorial tumors grade 3 or 4) that has
been previously treated with fractionated radiation therapy and now shows evidence of
2. Patients must have recovered from the toxic effects of prior therapy.
3. Patients must have recovered from the effects of surgery. There must be a minimum of
21 days from the day of surgery to the day of protocol treatment. For core or needle
biopsy, a minimum of 7 days must have elapsed prior to the day of protocol treatment.
4. Prior treatment with cytotoxic and biological agents is permissible. There should be
at least a 2-week break between prior treatment and the protocol treatment.
5. Prior treatment with fractionated radiation therapy (up to 60Gy) is an eligibility
criterion, however there should not have been a second course of fractionated
radiotherapy to the supratentorial area.
6. One prior single fraction radiosurgical procedure within the treatment field is
acceptable if V12<5 cc (V12 is the volume of normal brain (outside GTV) receiving 12
or more Gy). Additional radiosurgical procedures outside of the treatment area are
7. Subject must be able to take oral medication and to maintain a fast, is required for 2
hours before and 1 hour after MLN8237 administration.
8. ANC > 1500/mm³, platelets > 100,000/mm³, Hgb > 9 g/dL. Values must be obtained without
need for myeloid growth factor or platelet transfusion support within 14 days of
registration. However, erythrocyte growth factor is allowed as per published ASCO
9. Total bilirubin ? ULN, SGOT (AST) and SGPT (ALT)< 1.5 x ULN, within 14 days of
10. Adequate renal function as defined by: calculated creatinine clearance must be ?40
mL/minute (Cockcroft-Gault), within 14 days of registration.
11. Age >18 years.
12. ECOG performance status <2 (see Appendix I).
13. Life expectancy of greater than 2 months.
14. Women of childbearing potential must have a negative ?-HCG pregnancy test documented
within 7 days prior to registration.
15. 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
4 months after last dose.
16. Ability to understand and the willingness to sign a written informed consent document.
1. Known history of uncontrolled sleep apnea syndrome and other conditions that could
result in excessive daytime sleepiness such as severe chronic obstructive pulmonary
disease requiring supplemental oxygen.
2. Systemic infection requiring IV antibiotic therapy within 14 days preceding the first
dose of study drug, or other severe infection.
3. Myocardial infarction within 6 months prior to enrollment, New York Heart Association
(NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
conduction system abnormalities. Prior to study entry, any ECG abnormality at
Screening has to be documented by the investigator as not medically relevant.
4. Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum ?-human chorionic gonadotropin
(?-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for post-menopausal or surgically sterilized women.
5. Patient has received other investigational drugs within 14 days before enrollment
6. Serious medical or psychiatric illness likely to interfere with participation in this
7. Other severe acute or chronic medical or psychiatric condition, including uncontrolled
diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement
for pancreatic enzymes, any condition that would modify small bowel absorption of oral
medications, or laboratory abnormality that may increase the risk associated with
study participation or investigational product administration or may interfere with
the interpretation of study results and, in the judgment of the investigator, would
make the patient inappropriate for enrollment in this study.
8. Treatment with clinically significant enzyme inducers, such as the enzyme-inducing
antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin,
rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237 and
during the study.
9. Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C. Testing is not required in the absence of clinical findings or suspicion.
10. Patients have a history of any other malignancy from which the patient has been
disease-free for less than 2 years, with the exception of adequately treated basal or
squamous cell carcinoma of skin, superficial bladder cancer or carcinoma in situ of
cervix, AJCC (version 7.0) stage 0 or I breast cancer, AJCC (version 7.0) stage I, or
II prostate cancer.
11. Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is
considered to be over 25%.
12. Patients who cannot swallow whole tablets (i.e. medication tablets)
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