Clinical trial · Interventional
Sunitinib in Sarcomas of the Central Nervous System
Phase II Clinical Trial of Sunitinib in Sarcomas of the Central Nervous System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
Background: 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. Objective: To study the effects of Sunitinib on gliosarcomas or sarcomas of the central nervous system. Eligibility: Adults ages 18 and older with a gliosarcoma or sarcoma of the central nervous system Design: Participants will be screened with the following tests. Some may be done as part of their regular cancer care: Medical history Medication review Physical exam 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Sarcoma | Central Nervous System Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
| wGT3x-BT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Participants With Primary Gliosarcoma
- description
- Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest. Participants will be given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles
- interventionNames
- Drug: Sunitinib
- Device: wGT3x-BT
- type
- EXPERIMENTAL
- label
- Participants With Secondary Gliosarcoma
- description
- Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest. Participants will be given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles
- interventionNames
- Drug: Sunitinib
- Device: wGT3x-BT
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Patients must have histologically confirmed gliosarcoma (primary or secondary) or primary central nervous system sarcoma confirmed by the Laboratory of Pathology, National Cancer Institute (NCI). * Patients must have measurable disease, defined as at least one lesion that can be accurately measured bi-dimensionally by MRI (or computed tomography (CT) scan if magnetic resonance imaging (MRI) is contraindicated). * Patients must have failed standard therapy consisting of surgery, irradiation, and chemotherapy if indicated. * Age greater than or equal to 18 years. * Karnofsky greater than or equal to 60%. * Patients must have normal organ and marrow function as defined below: * leukocytes greater than or equal to 3,000/mcL * absolute neutrophil count greater than or equal to 1,500/mcL * platelets greater than or equal to 100,000/mcL * total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 times institutional upper limit of normal * creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal. * Patients must have the ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study. * The effects of sunitinib on the developing human fetus are unknown. For this reason and because anti-angiogenic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Tumor tissue blocks or at least 10-15 unstained slides from the diagnosis should be available. * At the time of registration, all subjects must be removed greater than or equal to 28 days from any investigational agents. EXCLUSION CRITERIA: * Patients who are receiving any other investigational agents. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Prior use of tyrosine kinase inhibitors or vascular endothelial growth factor (VEGF) inhibition. * Patients who are receiving strong cytochromes P450 (CYP450) inducers or inhibitors are ineligible. * Pregnant women are excluded from this study because sunitinib has potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib, breastfeeding should be discontinued if the mother is treated with sunitinib. * Patients with known human immunodeficiency virus (HIV) history on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Uncontrolled hypertension (\> 150/100 mm hemoglobin (Hg) while on antihypertensive medications. * New York Heart Association class II or greater congestive heart failure. * Serious cardiac arrhythmia requiring medication. * Baseline echocardiogram with ejection fraction \< 50% or greater than or equal to 20% decrease from a prior study. * Corrected QT interval (QTc) \> 500 msec on baseline electrocardiogram (EKG) * Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis. Note: Low molecular weight heparin is permitted provided the patient's international normalized ratio (INR) is less than or equal to 1.5. * Previous exposure to anthracyclines.
References
Publications (3)
- BACKGROUNDKondo T, Takagi T, Kobayashi H, Iizuka J, Nozaki T, Hashimoto Y, Ikezawa E, Yoshida K, Omae K, Tanabe K. Superior tolerability of altered dosing schedule of sunitinib with 2-weeks-on and 1-week-off in patients with metastatic renal cell carcinoma--comparison to standard dosing schedule of 4-weeks-on and 2-weeks-off. Jpn J Clin Oncol. 2014 Mar;44(3):270-7. doi: 10.1093/jjco/hyt232. Epub 2014 Jan 27. PMID 24474815
- BACKGROUNDCachia D, Kamiya-Matsuoka C, Mandel JJ, Olar A, Cykowski MD, Armstrong TS, Fuller GN, Gilbert MR, De Groot JF. Primary and secondary gliosarcomas: clinical, molecular and survival characteristics. J Neurooncol. 2015 Nov;125(2):401-10. doi: 10.1007/s11060-015-1930-y. Epub 2015 Sep 9. PMID 26354773
- BACKGROUNDFinke J, Ko J, Rini B, Rayman P, Ireland J, Cohen P. MDSC as a mechanism of tumor escape from sunitinib mediated anti-angiogenic therapy. Int Immunopharmacol. 2011 Jul;11(7):856-61. doi: 10.1016/j.intimp.2011.01.030. Epub 2011 Feb 11. PMID 21315783