Trial · NCT03641326
Sunitinib in Sarcomas of the Central Nervous System
NCT03641326, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2022-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sunitinib in Sarcomas of the Central Nervous System. Trials, record NCT03641326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03641326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib in Sarcomas of the Central Nervous System
- NCT number
- NCT03641326
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Gliosarcoma, Central Nervous System Sarcoma
- Interventions
- Sunitinib, wGT3x-BT
- First posted
- 2018-08-22
- Last updated
- 2022-04-19
- Results first posted
- 2022-04-19
- Limitations and caveats
National Institutes of Health (NIH) clinical center is a quaternary care facility where we rely heavily on self-referrals and outside physician referrals for accrual. Competing trials at NIH and outside institutions have shifted interest from this study and physicians are not referring patients for this study. Consequently, we have had low accrual.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Greater Than 50% Reduction in Objective Response | From enrollment to off study, approximately 3 Months, 1 Week, 4 Days | Objective Response is defined as all participants who had greater than 50% reduction in Complete Response and Partial Response assessed by the Assessment in Neuro-oncology Criteria (RANO criteria). Complete Response is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) or clinical status. Partial Response is ≥50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increasing clinical status. |
| Secondary | Number of Participants With 6-month Progression Free Survival (PFS) | 6 months | Progression is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. PFS was assessed by the Response Assessment in Neuro-oncology Criteria (RANO criteria). Progression is ≥25% increase in T1 gadolinium enhancing disease, increase in T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR), presence of new lesions, and decrease in clinical status. |
| Secondary | Number of Participants That Have Progressive Disease After 18 Months | After 18 months | Progressive disease was assessed by the Response Assessment in Neuro-oncology Criteria (RANO criteria). Progression is ≥25% increase in T1 gadolinium enhancing disease, increase in T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR), presence of new lesions, and decrease in clinical status. |
| Secondary | Number of Adverse Events Related to Drug | Baseline to off study, approximately 3 months and 12 days | Adverse events was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Evaluation of Tumor Tissue for Biomarkers | end of study, approximately 25 months and 12 days. | To evaluate archival tumor tissue for activation of signaling pathways targeted by sunitinib to establish potential biomarkers of response. |
| Secondary | Number of Responders and Non-responders With Tumor Markers of Activation | From baseline to end of treatment, approximately 25 months and 12 days. | Molecular profiling of archival tumor tissues was used to identify tumor markers of activation of response to sunitinib in responders and non-responders. A responder is a participant with a Complete Response (CR) or Partial Response (PR), and a non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD) assessed by the Response Assessment in Neuro-oncology Criteria (RANO criteria). CR is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR). PR is ≥50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increasing clinical status. SD is \<50% decrease in T1 gadolinium enhancing disease but \< 25% increase, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increase in clinical status. PD is ≥25% increase in T1 gadolinium enhancing disease. |
| Secondary | Number of Responders and Non-responders With a Change in Perfusion Blood Volume Before and After Treatment With Sunitinib. | Pre-treatment and post treatment, approximately 25 months and 12 days. | Perfusion was quantitated in responders and non-responders comparing pre and post treatment to determine if the treatment regimen altered vasculature and blood flow to the tumor. A responder is a participant with a Complete Response (CR) or Partial Response (PR), and a non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD) assessed by the Response Assessment in Neuro-oncology Criteria (RANO criteria). CR is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR). PR is ≥50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increasing clinical status. SD is \<50% decrease in T1 gadolinium enhancing disease but \<25% increase, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increase in clinical status. PD is ≥25% increase in T1 gadolinium enhancing disease. |
| Secondary | Number of Responders and Non-responders With Dynamic Contrast Enhanced Magnetic Resonance Imaging (MRI) Performed Before and During Treatment With Sunitinib. | Before (baseline) and during treatment with Sunitinib every 6 weeks, up to approximately 25 months and 12 days. | Dynamic contrast enhanced magnetic resonance imaging (MRI) was performed before and during treatment with sunitinib in responders and non-responders. A responder is a participant with a Complete Response (CR) or Partial Response (PR), and a non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD) assessed by the Response Assessment in Neuro-oncology Criteria (RANO criteria). CR is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR). PR is ≥50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increasing clinical status. SD is \<50% decrease in T1 gadolinium enhancing disease but \< 25% increase, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increase in clinical status. PD is ≥25% increase in T1 gadolinium enhancing disease. |
| Secondary | Mean Symptom Severity and Interference From Baseline Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) | Baseline and off treatment, approximately 25 months and 12 days | Participants reported outcome measures using a self-reported symptom severity and interference with daily activities using the MDASI-BT. The MDASI-BT consists of symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. All patients with at least one valid questionnaire will be included in the analyses. This outcome measure was predicated on change. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures. |
| Other | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Baseline to off study, approximately 3 months and 12 days | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Greater Than 50% Reduction in Objective Response | From enrollment to off study, approximately 3 Months, 1 Week, 4 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With 6-month Progression Free Survival (PFS) | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Have Progressive Disease After 18 Months | After 18 months | This outcome measure was not analyzed because none of the participants reached 6 months progression free survival (PFS), thus we could not assess participants for 18 months PFS. | ||
| SECONDARY | Number of Adverse Events Related to Drug | Baseline to off study, approximately 3 months and 12 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Evaluation of Tumor Tissue for Biomarkers | end of study, approximately 25 months and 12 days. | Analysis not done. There were not enough samples collected to provide results. | ||
| SECONDARY | Number of Responders and Non-responders With Tumor Markers of Activation | From baseline to end of treatment, approximately 25 months and 12 days. | 0 participants achieved a response in the responders with primary gliosarcoma group and responders with secondary gliosarcoma group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Responders and Non-responders With a Change in Perfusion Blood Volume Before and After Treatment With Sunitinib. | Pre-treatment and post treatment, approximately 25 months and 12 days. | This outcome measure was not done because no data was collected because the perfusion blood volume was not measured. | ||
| SECONDARY | Number of Responders and Non-responders With Dynamic Contrast Enhanced Magnetic Resonance Imaging (MRI) Performed Before and During Treatment With Sunitinib. | Before (baseline) and during treatment with Sunitinib every 6 weeks, up to approximately 25 months and 12 days. | 0 participants achieved a response in the responders with primary gliosarcoma group and responders with secondary gliosarcoma group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Symptom Severity and Interference From Baseline Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) | Baseline and off treatment, approximately 25 months and 12 days | 2 participants only had baseline MDASI, \& 1 participant had baseline\&off treatment MDASI in the secondary glioblastoma group. The number of participants enrolled =5 \& analyses were performed on a subset of collected data. No conclusions should be drawn from the reported data on whether participants had a change in quality of life. Only treatment toxicity evaluation is meaningful \& this will not vary by the histologic subtype of the tumor. Thus, combining the 2 groups is most logical \& expedient. | Score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Baseline to off study, approximately 3 months and 12 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Greater Than 50% Reduction in Objective Response | Participants With Primary Gliosarcoma | Complete Response | 0 | Participants | |
| Number of Participants With Greater Than 50% Reduction in Objective Response | Participants With Secondary Gliosarcoma | Complete Response | 0 | Participants | |
| Number of Participants With Greater Than 50% Reduction in Objective Response | Participants With Primary Gliosarcoma | Partial Response | 0 | Participants | |
| Number of Participants With Greater Than 50% Reduction in Objective Response | Participants With Secondary Gliosarcoma | Partial Response | 0 | Participants | |
| Number of Participants With 6-month Progression Free Survival (PFS) | Participants With Primary Gliosarcoma | 0 | Participants | ||
| Number of Participants With 6-month Progression Free Survival (PFS) | Participants With Secondary Gliosarcoma | 0 | Participants | ||
| Number of Adverse Events Related to Drug | Participants With Primary Gliosarcoma | 0 | Participants | ||
| Number of Adverse Events Related to Drug | Participants With Secondary Gliosarcoma | 0 | Participants | ||
| Number of Responders and Non-responders With Tumor Markers of Activation | Responders With Primary Gliosarcoma | 0 | Participants | ||
| Number of Responders and Non-responders With Tumor Markers of Activation | Non-Responders With Primary Gliosarcoma | 1 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Primary Gliosarcoma | 2 | |
| Overall Study | STARTED | Participants With Secondary Gliosarcoma | 3 | |
| Overall Study | COMPLETED | Participants With Primary Gliosarcoma | 2 | |
| Overall Study | COMPLETED | Participants With Secondary Gliosarcoma | 3 | |
| Overall Study | NOT COMPLETED | Participants With Primary Gliosarcoma | 0 | |
| Overall Study | NOT COMPLETED | Participants With Secondary Gliosarcoma | 0 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Participants With Primary Gliosarcoma | 1 | 2 | 1 |
| other | Alanine aminotransferase increased | Investigations | Participants With Secondary Gliosarcoma | 1 | 3 | 2 |
| other | Alkaline phosphatase increased | Investigations | Participants With Primary Gliosarcoma | 0 | 2 | 0 |
| other | Alkaline phosphatase increased | Investigations | Participants With Secondary Gliosarcoma | 1 | 3 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Participants With Primary Gliosarcoma | 0 | 2 | 0 |
| other | Aspartate aminotransferase increased | Investigations | Participants With Secondary Gliosarcoma | 1 | 3 | 1 |
| other | Constipation | Gastrointestinal disorders | Participants With Primary Gliosarcoma | 0 | 2 | 0 |
| other | Constipation | Gastrointestinal disorders | Participants With Secondary Gliosarcoma | 1 | 3 | 1 |
| other | Creatinine increased | Investigations | Participants With Primary Gliosarcoma | 1 | 2 | 1 |
| other | Creatinine increased | Investigations | Participants With Secondary Gliosarcoma | 0 | 3 | 0 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Primary Gliosarcoma | 2 | 2 |
| Total, all-cause mortality | Participants With Secondary Gliosarcoma | 2 | 3 |
| Total, other adverse events | Participants With Primary Gliosarcoma | 2 | 2 |
| Total, other adverse events | Participants With Secondary Gliosarcoma | 3 | 3 |
| Total, serious adverse events | Participants With Primary Gliosarcoma | 2 | 2 |
| Total, serious adverse events | Participants With Secondary Gliosarcoma | 3 | 3 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Participants With Primary Gliosarcoma vs Participants With Secondary Gliosarcoma: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Participants With Primary Gliosarcoma vs Participants With Secondary Gliosarcoma: Number of Participants With 6-month Progression Free Survival (PFS) | Trial comparisons |
| Participants With Primary Gliosarcoma vs Participants With Secondary Gliosarcoma: Number of Adverse Events Related to Drug | Trial comparisons |
| Participants With Primary Gliosarcoma vs Participants With Secondary Gliosarcoma: deaths from any cause | Trial comparisons |
| Participants With Primary Gliosarcoma vs Participants With Secondary Gliosarcoma: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03641326
GET https://conductscience.org/api/trials/v1/NCT03641326/results?page=2