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
PRIMARY OBJECTIVES: I. Determine the therapeutic efficacy of pazopanib hydrochloride, as measured by 6-month progression-free survival (PFS), in patients with recurrent glioblastoma. II. Determine the safety profile of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the efficacy of this drug, as measured by radiographic response, time to progression, and overall survival, in these patients. OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for at least 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given orally
Correlative studies
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
6 Months Progression-free Survival
Calculated from study registration till 6month time point. Progression defined by Macdonald criteria Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Time frame: 6 months
Number of Participants Discontinuing Treatment Due to Toxicity
Use NCI Common toxicity Criteria Adverse Event Version 3.0 to grade toxicities. Any patient who received at least one dose of pazopanib was evaluable for toxicity. Calculated the number of participants who had an event that was related to pazopanib that caused the patient to stop treatment due to this event.
Time frame: 2 years
Most Common Toxicities Experienced After at Least One Dose of Pazopanib
NCI Common Toxicity Criteria (CTCAE) version 3.0. All patients that received at least one dose of pazopanib were evaluable. All events recorded that were related to drug were calculated per patient.
Time frame: Up to 2 years
Overall Radiographic Response (ORR) Rate
The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
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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
Time frame: 2 years
Best Radiographic Response
Using the Macdonald criteria, the best MRI image response while the patient was on active treatment. 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Time frame: 3 years
Overall Survival
calculated from study registration until date of death or patient censored at the last date known alive
Time frame: From date of registration to date of death due to any cause, assessed up to 2 years
Time to Progression or Progression Free Survival
PFS for patients who died on treatment or within 30 days of the end of treatment w/out progression date, was date of death. All other pts without documented progression were censored at the date of last follow-up prior to start new treatment. All 35 patients were included in an intent to treat analysis for PFS and OS. 3 pts censored for PFS, all less than 2 wks after study registration.
Time frame: 1 year