Sunitinib in Treating Patients With Recurrent Malignant Gliomas

Completed · Phase 2

Conditions studied: Adult Anaplastic Astrocytoma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Pineal Gland Astrocytoma

In brief

This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key facts

Study ID

NCT00499473

Run by

National Cancer Institute (NCI)

People needed

31

Starts

2007-06-01

Expected to finish

2014-10-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stratum 1:
• Currently not receiving an enzyme-inducing anticonvulsant
• Patients receiving non-enzyme inducing anticonvulsants are eligible for this stratum
• Histologically confirmed WHO grade IV astrocytoma (glioblastoma multiforme [GBM]) including gliosarcoma
• Stratum 2 (USA patients only):
• Currently on stable dose of an enzyme-inducing anticonvulsant (with confirmed therapeutic serum levels) for at least 2 weeks prior to study registration including any of the following:
• Phenytoin
• Carbamazepine
• Phenobarbital
• Histologically confirmed grade IV astrocytoma (GBM), gliosarcoma, grade III astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
• All patients must have unequivocal evidence of tumor progression by MRI or CT scan performed no longer than 14 days prior to study registration
• Patients undergoing surgery for progressive disease with nonmeasurable disease on post-operative MRI, ideally obtained within 48 hours of surgery, (i.e., macroscopic gross total resection) are eligible
• ECOG performance status 0-2 (Karnofsky ≥ 60%)
• Life expectancy > 3 months
• Leukocytes ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Serum calcium ≤ 12.0 mg/dL
• Total bilirubin within normal institutional limits (ULN)
• AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
• Creatinine < 1.5 X institutional ULN
• Patients must have QTc < 500 msec
• The following groups of patients are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO or MUGA:
• Those with a history of class II heart failure who are asymptomatic on treatment

You may not qualify if…

• History of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
• Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiation therapy within 12 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• At least 4 weeks must have elapsed since any major surgery

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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