Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab

Summary

Background: Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat lung cancer. Both topotecan and pazopanib have individually been used to treat patients with glioblastoma and some anti-tumor activity has been found. Researchers want to see if these two drugs together may be able to help people with glioblastoma. Objectives: To learn if pazopanib with topotecan can help control glioblastoma. Also, to study the safety of this drug combination. Eligibility: Adults at least 18 years old whose glioblastoma has returned after treatment. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Brain computed tomography (CT) or magnetic resonance imaging (MRI) For these, participants lay in a machine that takes pictures. Chest CT scan or x-ray Heart electrocardiogram (EKG) A questionnaire about quality of life Participants will be assigned to a study group. Participants will take the study drugs for 28-day cycles for up to 1 year. They will take capsules of topotecan by mouth once every day. They will take tablets of pazopanib by mouth once every day. Participants will write in a diary the times they take the study drugs. Participants will have several study visits during each cycle. These may include Blood pressure measurement Blood and urine tests EKG Physical exam and/or neurological exam Brain MRI or CT scan to check the status of the disease A symptom questionnaire At the end of treatment, participants will have a physical exam. They may have blood drawn. Participants will have follow-up calls once every 3 months to check.

Timeline

Start

2015-12-10

Primary completion

2019-09-12

Completion

2019-09-12

Publications

• Background Macdonald D, Cairncross G, Stewart D, Forsyth P, Sawka C, Wainman N, Eisenhauer E. Phase II study of topotecan in patients with recurrent malignant glioma. National Clinical Institute of Canada Clinical Trials Group. Ann Oncol. 1996 Feb;7(2):205-7. doi: 10.1093/oxfordjournals.annonc.a010550.
• Background Armstrong TS, Mendoza T, Gning I, Coco C, Cohen MZ, Eriksen L, Hsu MA, Gilbert MR, Cleeland C. Validation of the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT). J Neurooncol. 2006 Oct;80(1):27-35. doi: 10.1007/s11060-006-9135-z. Epub 2006 Apr 6.
• Background Vredenburgh JJ, Desjardins A, Herndon JE 2nd, Marcello J, Reardon DA, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Sampson J, Wagner M, Bailey L, Bigner DD, Friedman AH, Friedman HS. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol. 2007 Oct 20;25(30):4722-9. doi: 10.1200/JCO.2007.12.2440.

Drugs

Indications