Trial · NCT02715609
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of DSF (Dose-escalation Phase Only) | Estimated to be 2 years and 28 weeks | * The maximum tolerated dose (MTD) of DSF is defined as the dose level at which 20% of the cohort experience dose-limiting toxicity (DLT) within 18 weeks from start of RT (or 12 weeks from the end of RT if there is a delay in RT). MTD is assessed from the first dose of DSF in combination with TMZ and RT; patients will not be assessed for DLT during the pre-surgery period when they are receiving the lead-in doses of DSF. * A DLT is defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications/TMZ which occurs within 18 weeks following the first dose of DSF with RT+TMZ (corresponding to approximately 6 weeks during RT and 12 weeks after RT) |
| Primary | Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | 1 year | |
| Primary | Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | 2 years | |
| Primary | Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | 3 years | |
| Primary | Mean Overall Survival (Dose-expansion Phase Only) | Through completion of follow-up (up to 5 years) | |
| Secondary | Toxicity of DSF When Given Concurrently With Radiation Therapy and Temozolomide as Measured by the Grade and Frequency of Grade 2 or Greater Adverse Events Related to DSF | Through completion of DSF treatment (up to 38 weeks) | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Secondary | Intratumor and Plasma Concentration of DSF Metabolite (Ditiocarb-copper Complex) | At the time of surgery (day 4) | Will be determined using mass spectrometer |
| Secondary | Mean Progression-free Survival (PFS) | Through completion of follow-up (up to 5 years) | Will be determined from the first day of RT to the time of tumor progression or death, whichever occurs first. Tumor progression will be determined using the RANO criteria. |
| Other | Rate of Pseudo-progression (PsP) | Through completion of follow-up (up to 5 years) | -Pseudoprogression is defined as a transient increase of tumor after chemoradiotherapy that subsequently stabilizes without a change of therapy |
| Other | Pharmacodynamic Studies on Glutamate Metabolism as Measured by Measurement of Glutamine Levels in Plasma and Tumor Tissues | Week 6 | |
| Other | Pharmacodynamic Studies on Glutamate Metabolism as Measured by Measurement of Glutamate Levels in Plasma and Tumor Tissues | Week 6 | |
| Other | Time to Tumor Progression (TTP) (Dose-escalation Phase Only) | Through completion of follow-up (up to 5 years) | -≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids. The absolute increase in any dimension must be at least 5mm when calculating the products * Significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy not caused by comorbid events * Any new measureable lesion * Clear clinical deterioration not attributable to other causes apart from the tumor (e.g. seizures, medication adverse effects, complications of therapy, cerebrovascular events, infection, and so on) or changes in corticosteroid dose * Failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease |
| Other | Pharmacodynamic Studies on Glutamate Metabolism as Measured by Measurement of Aspartate Levels in Plasma and Tumor Tissues | Week 6 | |
| Other | Pharmacodynamic Studies on Glutamate Metabolism as Measured by Measurement of Glucose Levels in Plasma and Tumor Tissues | Week 6 | |
| Other | Pharmacodynamic Studies on Glutamate Metabolism as Measured by Measurement of Lactate Levels in Plasma and Tumor Tissues | Week 6 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02715609/registered