Pazopanib in Treating Patients With Recurrent Glioblastoma

Completed · Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

In brief

This phase II trial is studying the side effects and how well pazopanib works in treating patients with recurrent glioblastoma. Pazopanib 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

NCT00459381

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2007-05-01

Expected to finish

2008-12-01

Last updated by the study team

2017-03-15

Who can join

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

You may qualify if…

• Histologically confirmed glioblastoma multiforme, including gliosarcoma
• Recurrent disease
• Must have unequivocal radiographic evidence of tumor progression by MRI, as defined by any of the following:
• 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline
• Clear worsening of any evaluable disease
• Appearance of any new lesions or site
• Clear clinical worsening
• Must have failed prior radiotherapy that was completed ≥ 42 days ago
• Patients who received prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease, rather than radiation necrosis, based on positron emission tomography (PET) scan, thallium scanning, magnetic resonance spectroscopy, or surgical documentation of disease
• Treatment for no more than 2 prior relapses allowed
• Relapse is defined as progression following initial therapy (i.e., radiotherapy with or without chemotherapy, if that was used as initial therapy; therefore no more than 3 prior therapies [initial therapy and therapy for 2 relapses] allowed)
• If the patient had a surgical resection for relapsed disease and no anticancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered as 1 relapse
• For patients who had prior therapy for a low-grade glioma, the surgical diagnosis of a glioblastoma multiforme will be considered the first relapse
• Karnofsky performance status 60-100%
• Life expectancy > 8 weeks
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Hemoglobin ≥ 10 g/dL (may be reached by transfusion)
• Platelet count ≥ 100,000/mm\^3
• PT/INR/PTT ≤ 1.2 times upper limit of normal (ULN)
• SGOT < 2.5 times ULN
• Bilirubin < 2.5 times ULN
• Creatinine < 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
• Urine protein:creatinine ratio > 1 OR urine protein < 1,000 mg by 24-hour urine collection OR proteinuria < 1+
• Not pregnant or nursing

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• National Cancer Institute Neuro-Oncology Branch — Bethesda, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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