A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma

Glioblastoma Clinical Trial

Official title: A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme

Status Completed

Clinical Trial Summary

We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).

The purposes of this study are:

• To see if Sutent has any change on the patient and their cancer.

• To see if Sutent will slow or stop the growth of their tumor.

• To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer.

Clinical Trial Description

Trial patients received sunitinib 50 mg daily for 4 weeks without regard to meals, followed by a 2-week rest period. This 6-week regimen constituted 1 cycle. Patients were treated for up to 9 cycles [~ year) or until disease progression or death or if persistent toxicities occurred. Complete blood count with differential, complete metabolic profile, neurologic exam, and brain magnetic resonance imaging (MRI) with contrast were obtained after each cycle. Toxicity assessments were obtained after each cycle. Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0.

SCHEDULE OF EVENTS - PROTOCOL ACTIVITIES

<14 Days Prior to Initial Study Treatment:

• Neurological/Oncological History

• Neurological Examination

• Height/Weight/Body Surface Area

• Performance Status

• Quality of Life (QOL) FACT-L

• Laboratory Studies; complete blood count (CBC), Differential, Platelets, prothrombin time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), Serum Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), Total Bilirubin, alkaline phosphatase (AlkPHs), Pregnancy Test, electrocardiogram (EKG)

• Cranial MRI or CT with and without contrast

• Multiple uptake gated acquisition (MUGA) Scan

Day 1, At the Beginning of Each Treatment Cycle:

• Adverse Event Assessment

• Laboratory Studies; CBC, Differential, Platelets

Every Cycle, Days 42-45 (within 3 days of next scheduled Sutent treatment):

• Neurological/Oncological History

• Neurological Examination

• Height/Weight/Body Surface Area

• Performance Status

• QOL FACT-L

• Laboratory Studies; Serum Creatinine, BUN, ALT, AST, LDH, Total Bilirubin, AlkPHs

• Cranial MRI or CT with and without contrast

• Survival

At Off Study:

• Performance Status

• Cranial MRI or CT with and without contrast

• Survival ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaplastic Astrocytoma
• Astrocytoma
• Glioblastoma

• NCT number: NCT00606008
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Status: Completed
• Phase: Phase 2
• Start date: March 2007
• Completion date: August 2012