SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to … (NCT00004868) | Clinical Trial Compass
CompletedPhase 1/2
SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy
United StatesStarted 2000-03-24
Plain-language summary
RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically proven supratentorial malignant primary glioma, including:
* Glioblastoma multiforme
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic mixed oligoastrocytoma
* Malignant astrocytoma not otherwise specified
* Benign or malignant meningiomas, including brain and spinal meningiomas
* Patients with meningiomas are excluded from phase II portion of study
* Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI
* Must have failed prior radiotherapy
* Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days
* Must be on stable (unchanged) dose of steroids for at least 5 days before scans
* Phase II:
* Must have completed radiotherapy at least 2 months prior to enrollment
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 8 weeks
Hematopoietic:
* WBC at least 2,300/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL (transfusion allowed)
Hepatic:
* SGOT less than 2.5 times upper limit of normal
* Bilirubin normal
* No significant active hepatic disease
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
* No significant active renal disease
Cardiovascular:
* No uncompensated coronary artery disease on ECG or physical examination
* No history of myocardial infarction or severe/unstable angi…
Trial details
NCT IDNCT00004868
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins