Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Gra… (NCT02186509) | Clinical Trial Compass
CompletedPhase 1
Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas
United States17 participantsStarted 2015-01-30
Plain-language summary
This phase I trial studies the side effects and best dose of alisertib when combined with fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the growth of tumor cells by blocking an enzyme needed for the cells to divide. Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic radiosurgery uses special positioning equipment to send a single high dose of radiation directly to the tumor and cause less damage to normal tissue. Delivering stereotactic radiosurgery over multiple doses (fractionation) may cause more damage to tumor tissue than normal tissue while maintaining the advantage of its accuracy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 recurrence.
✓. Patients must have recovered from the toxic effects of prior therapy.
✓. 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.
✓. 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.
✓. 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.
✓. 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 acceptable.
✓. 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.
What they're measuring
1
Maximum Tolerated Dose (MTD) of Alisertib
Timeframe: Up to 30 days after completion of radiation therapy
Trial details
NCT IDNCT02186509
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
✓. 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 guidelines.
Exclusion criteria
✕. 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.
✕. Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
✕. 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.
✕. Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
✕. Patient has received other investigational drugs within 14 days before enrollment
✕. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
✕. 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.
✕. 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.