Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab
NCT01931098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-08-11
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.
Conditions
- Glioblastoma
- Glioblastoma Multiforme
- Gliosarcoma
- Brain Neoplasms
- Central Nervous System Neoplasms
Interventions
- DRUG
-
topotecan
Taken .25 mg orally, daily continuous until progression up to one year.
- DRUG
-
pazopanib
600 mg orally, daily until progression, up to one year.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Kevin Camphausen, M.D. · National Cancer Institute (NCI)
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-10
- Primary Completion
- 2019-09-12
- Completion
- 2019-09-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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