Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01026493
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Any intracranial high-grade glioma (phase I\*)
* Glioblastoma or gliosarcoma (phase II\*)
* Patients whose original histology was low-grade glioma are eligible provided they were subsequently diagnosed with glioblastoma or gliosarcoma
* Unequivocal radiographic evidence for tumor progression by MRI within 14 days prior to registration and with a stable or decreasing dose of steroids at least 5 days prior to scanning OR recent resection (registration within 30 days of resection) as long as all of the following conditions are met:
* Patients must have recovered from the effects of surgery
* Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a post-operative MRI scan should be performed within 28 days prior to registration and within 96 hours post surgery (although 24 hours would be optimum)
* Prior radiation is required for the phase I\* arm
* Patients must have completed a course of radiation therapy and at least 2 consecutive adjuvant cycles of temozolomide (phase II\*)
* A stable or decreasing dose of steroids at least 5 days prior to scanning is not mandated for patients who had a recent resection
* No evidence of acute (i.e., new and active) intratumoral hemorrhage on MRI
* Patients with MRI demonstrating old hemorrhage or subacute blood after a neurosurgical procedure (biopsy or resection) are eligible Note: \*Phase I was closed and phase II was opened on 3/6/12.
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* White blood cell (WBC) count ≥ 3,000/mm\^3
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
* Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3.0 times upper limit of normal (ULN)
* Serum glutamic pyruvic transaminase (SGPT) ≤ 3.0 times ULN
* Bilirubin ≤ 1.25 times ULN
* Creatinine \< 1.7 mg/dL OR estimated glomerular filtration rate (GFR) ≥ 30 mL/min
* Urine protein:creatinine ratio ≤ 0.5 OR urine protein \< 1,000 mg by 24-hour urine collection\*\*
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
* Able to undergo brain MRI scans with IV gadolinium
* Able to swallow oral medications
* Patients with a history of seizure, or new onset of seizures, should be clinically controlled with no seizures for at least 14 days prior to registration
* No other prior invasive malignancy (except for nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease-free and off therapy for that disease for ≥ 3 years
* No severe, active comorbidity, including any of the following:
* Transmural myocardial infarction or unstable angina within the past 6 months
* Evidence of recent myocardial infarction or ischemia as indicated by S-T elevations of ≥ 2 mm on EKG performed within the past 14 days
* New York Heart Association (NYHA) class II-IV congestive heart failure requiring hospitalization within the past 12 months
* Stroke or transient ischemic attack within the past 6 months
* Cerebral vascular accident within the past 6 months
* Serious and inadequately controlled cardiac arrhythmia
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Serious non-healing would, ulcer, or bone fracture
* Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within the past 28 days
* Significant traumatic injury within the past 28 days
* Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 14 days
* AIDS based upon current Centers for Disease Control and Prevention (CDC) definition (HIV testing is not required)
* No condition that would impair the ability to swallow pills (e.g., GI tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
* No disease that would obscure toxicity or dangerously alter drug metabolism
* Not on dialysis
* No history of chronic hepatitis B or C Note: \*\*Required for patients who received prior bevacizumab and developed known clinically significant nephrotic syndrome during treatment and whose baseline values have not returned to normal.
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from the toxic effects of prior therapy
* Prior interstitial brachytherapy, Gliadel wafer, or stereotactic radiosurgery allowed provided there is confirmation of progressive disease by positron emission tomography (PET) scan, thallium scan, MRI spectroscopy, perfusion MRI, or surgical documentation
* No more than 3 prior treatment regimens (phase I\*)
* No more than 2 prior treatment regimens for recurrent glioblastoma/gliosarcoma (phase II\*)
* More than 28 days since prior major surgical procedure or open biopsy (with the exception of craniotomy)
* At least 28 days since prior investigational agents or cytotoxic agents (42 days for nitrosoureas, 21 days for procarbazine, and 14 days for vincristine)
* At least 14 days since prior non-cytotoxic agents (e.g., bevacizumab, interferon, tamoxifen, thalidomide, isotretinoin, or tyrosine kinase inhibitors)
* No concurrent highly-active antiretroviral therapy
* No concurrent herbal products of unknown constitution
* No concurrent major surgical procedures Note: \*Phase I was closed and phase II was opened on 3/6/12.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01026493
Study Brief:
Protocol Section:
NCT01026493