Sunitinib in Sarcomas of the Central Nervous System
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|ClinicalTrials.gov Identifier: NCT03641326|
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : May 10, 2021
A sarcoma is a rare cancer. It grows in the body s connective tissue. Sarcomas in the brain and central nervous system are especially rare. The drug Sunitinib has been approved in many countries for treating other types of rare or advanced cancers. These include kidney, pancreas, and bowel cancer. Researchers want to see if it can help people with sarcomas of the central nervous system.
To study the effects of Sunitinib on gliosarcomas or sarcomas of the central nervous system.
Adults ages 18 and older with a gliosarcoma or sarcoma of the central nervous system
Participants will be screened with the following tests. Some may be done as part of their regular cancer care:
Blood, heart, and pregnancy tests
Cranial scans to locate and measure their tumor
Participants will take Sunitinib by mouth every day for 2 weeks and then take none of the drug for 1 week. These 3 weeks equal 1 cycle.
Participants will have 2 study visits in cycle 1. They will have 1 visit in all other cycles. They will answer questions about quality of life and repeat some screening tests.
Participants will take their blood pressure at home weekly. They keep a diary of each dose of Sunitinib and blood pressure reading.
Participants can choose to share data about their physical activity levels and quality of sleep. These participants will wear a small, portable watch-sized accelerometer device on the wrist for 6 cycles.
About 1 month after their last study drug dose, participants will have a final study visit. They will have a physical exam, blood tests, and scans.
|Condition or disease||Intervention/treatment||Phase|
|Gliosarcoma Central Nervous System Sarcoma||Drug: Sunitinib Device: wGT3x-BT||Phase 2|
- Gliosarcoma and primary CNS sarcomas are malignant brain tumors uniformly associated with poor outcome.
- There are no known effective medical therapies for these cancers.
- Sunitinib is an orally administered small molecule that inhibits signaling of multiple receptor tyrosine kinases including those known to be activated in CNS sarcomas.
To determine the anti-tumor effect of sunitinib in recurrent gliosarcomas and primary CNS sarcomas as assessed by objective response rate (ORR).
- Patients with histologically proven gliosarcoma and primary CNS sarcoma at disease relapse after failing standard therapy (surgery and irradiation).
- Tumor tissue blocks or 15 unstained slides should be available
- Subjects must be greater than or equal to 18 years old.
- Karnofsky performance status of greater than or equal to 60
- Patients must have adequate organ function.
- Patients must not have received tyrosine kinase inhibitor(s) in the past.
- This is a prospective, single institution, single arm, multi-cohort phase II study of sunitinib in subjects with recurrent gliosarcoma and primary CNS sarcoma that have failed prior surgery and irradiation (unless radiation therapy was contraindicated).
- Subjects will be classified into three cohorts: 1) Primary gliosarcoma; 2) Secondary gliosarcoma; 3) Primary CNS sarcoma. Cohort expansion will be carried out at indication of promising response.
- Sunitinib will be administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
- Toxicity will be assessed every cycle by CTCAE version 5.0.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial of Sunitinib in Sarcomas of the Central Nervous System|
|Actual Study Start Date :||February 21, 2019|
|Actual Primary Completion Date :||April 2, 2021|
|Actual Study Completion Date :||April 2, 2021|
Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest.Participants will given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles
Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest until there is disease progression or development of intolerable side effects.
Participants will given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles
- objective response rate (ORR) [ Time Frame: Enrollment of 16, 24, and 32 study subjects ]To determine anti-tumor effect of sunitinib in recurrent gliosarcomas and primary CNS sarcomas as assessed by objective response rate (ORR)
- Proportion of patients that have progressive disease after 18 months and median amount of time subject survives after therapy [ Time Frame: 6 month and death ]To determine the 6-month and median progression-free survival rates.
- adverse event frequency [ Time Frame: end of study ]To determine the adverse event rate of sunitinib in patients with recurrent gliosarcoma and primary CNS sarcoma.
- Evaluation of Tumor Tissue for Biomarkers [ Time Frame: end of study ]To evaluate archival tumor tissue for activation of signaling pathways targeted by sunitinib to establish potential biomarkers of response.
- Molecular Profiling of Tumor Tissue [ Time Frame: end of study ]To perform broad unbiased molecular profiling of archival tumor tissues to identify potential novel biomarkers of response to sunitinib.
- proportion of patients who [ Time Frame: end of study ]To evaluate radiological parameters such as perfusion and dynamic contrast enhanced MRI before and during treatment with sunitinib.
- Proportion of patients that have improvement in quality of life [ Time Frame: at defined study timepoints and end of study ]To longitudinally evaluate patient reported outcome measures using self-reported symptom severity and interference with daily activities using the MDASI-BT
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): NCT03641326
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Mark R Gilbert, M.D.||National Cancer Institute (NCI)|