Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab
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|ClinicalTrials.gov Identifier: NCT01931098|
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : April 21, 2020
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.
To learn if pazopanib with topotecan can help control glioblastoma. Also, to study the safety of this drug combination.
Adults at least 18 years old whose glioblastoma has returned after treatment.
Participants will be screened with:
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Glioblastoma Multiforme Gliosarcoma Brain Neoplasms Central Nervous System Neoplasms||Drug: topotecan Drug: pazopanib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A)Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab|
|Study Start Date :||December 10, 2015|
|Actual Primary Completion Date :||September 12, 2019|
|Actual Study Completion Date :||September 12, 2019|
Topotecan and pazopanib are administered orallydaily
Taken .25 mg orally, daily continuous until progression up to one year.
600 mg orally, daily until progression, up to one year.
- progression free survival (PFS) at six months from patient registration for bevacizumab naive patients and PFS at 3 months for patients with prior bevacizumab treatment. [ Time Frame: six months and three months ]Proportion of patients that have progressive disease after 3 months and 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931098
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Mark R Gilbert, M.D.||National Cancer Institute (NCI)|