Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Gliosarcoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Tumor, Adult

Neuroepithelioma

Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

pazopanib hydrochloride

laboratory biomarker analysis

Howard Fine, MD

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.

Pazopanib in Treating Patients With Recurrent Glioblastoma

A Phase II Trial of GW786034 (Pazopanib) in Patients With Recurrent Glioblastoma

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

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.

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.

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

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

calculated from study registration until date of death or patient censored at the last date known alive

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.

National Cancer Institute (NCI)

Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

pazopanib hydrochloride: Given orally

laboratory biomarker analysis: Correlative studies

Treatment (Pazopanib Hydrochloride)

Age, Continuous

Sex: Female, Male

90-100

60-80

Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death

Karnofsky Performance Status Scale

Prior Radiotherapy

Time from Radiotherapy to study enrollment

Number of Prior chemotherapy reginmens

Surgery for recurrence for current progression prior to enrollment

Mark Gilbert, MD

6 Months Progression-free Survival

thrombotic/embolic

CNS hemorrhage

Number of Participants Discontinuing Treatment Due to Toxicity

hypertension

fatigue

elevated ALT

Most Common Toxicities Experienced After at Least One Dose of Pazopanib

34 pts had follow-up scans and wee evaluable for objective radiographic response (ORR)

Spots Global Cancer Trial Database for Pazopanib in Treating Patients With Recurrent Glioblastoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial