Trial · NCT02715609
Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
NCT02715609, Phase 1, Phase 2, Completed, Washington University School of Medicine; results first posted 2025-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma. Trials, record NCT02715609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02715609
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
- NCT number
- NCT02715609
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Glioblastoma Multiforme
- Interventions
- Disulfiram, Copper Gluconate, Surgery, Radiation, Temozolomide
- First posted
- 2016-03-22
- Last updated
- 2025-04-10
- Results first posted
- 2025-04-10
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of DSF (Dose-escalation Phase Only) | Estimated to be 2 years and 28 weeks | One participant was not evaluable in dose escalation - dose level 2 as the participant did not receive DSF + RT + TMZ. This outcome measure is not for dose expansion portion of the trial. | mg | NUMBER |
| PRIMARY | Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | 1 year | This outcome measure is for participants enrolled in dose expansion only. | percentage of participants-Kaplan Meier | NUMBER |
| PRIMARY | Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | 2 years | This outcome measure is for participants enrolled in dose expansion only. | percentage of participants-Kaplan Meier | NUMBER |
| PRIMARY | Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | 3 years | This outcome measure is for participants enrolled in dose expansion only. | percentage of participants-Kaplan Meier | NUMBER |
| PRIMARY | Mean Overall Survival (Dose-expansion Phase Only) | Through completion of follow-up (up to 5 years) | This outcome measure is for participants enrolled in dose expansion only. | months | MEAN |
| 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Intratumor and Plasma Concentration of DSF Metabolite (Ditiocarb-copper Complex) | At the time of surgery (day 4) | Only 3 patients had tumor resection after preoperative DSF/Cu administration. | ng/mL | NUMBER |
| SECONDARY | Mean Progression-free Survival (PFS) | Through completion of follow-up (up to 5 years) | months | MEAN | |
| OTHER_PRE_SPECIFIED | Rate of Pseudo-progression (PsP) | Through completion of follow-up (up to 5 years) | |||
| OTHER_PRE_SPECIFIED | Pharmacodynamic Studies on Glutamate Metabolism as Measured by Measurement of Glutamine Levels in Plasma and Tumor Tissues | Week 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of DSF (Dose-escalation Phase Only) | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2 & 3) | 375 | mg | ||
| Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 80 | percentage of participants-Kaplan Meier | ||
| Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 67 | percentage of participants-Kaplan Meier | ||
| Kaplan-Meier Estimate of Overall Survival (Dose-expansion Phase Only) | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 52 | percentage of participants-Kaplan Meier | ||
| Mean Overall Survival (Dose-expansion Phase Only) | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 37.4 | 95% Confidence Interval 26.2 to 48.6 | months | |
| 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 | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | Grade 2 nausea | 0 | Participants | |
| 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 | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | Grade 2 nausea | 2 | Participants | |
| 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 | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | Grade 2 nausea | 2 | Participants | |
| 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 | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | Grade 2 diarrhea | 0 | Participants | |
| 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 | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | Grade 2 diarrhea | 1 | Participants |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 9 | |
| Overall Study | STARTED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 10 | |
| Overall Study | STARTED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 16 | |
| Overall Study | COMPLETED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 8 | |
| Overall Study | COMPLETED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 10 | |
| Overall Study | COMPLETED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 15 | |
| Overall Study | NOT COMPLETED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 1 | |
| Overall Study | NOT COMPLETED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 0 | |
| Overall Study | NOT COMPLETED | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 1 |
Source ClinicalTrials.gov
Adverse events384
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 | Anemia | Blood and lymphatic system disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 1 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 3 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 0 | 16 | |
| other | Elevated heart rate | Cardiac disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 1 | 9 | |
| other | Elevated heart rate | Cardiac disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 0 | 10 | |
| other | Elevated heart rate | Cardiac disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 0 | 16 | |
| other | Ear pain | Ear and labyrinth disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 1 | 9 | |
| other | Ear pain | Ear and labyrinth disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 0 | 10 | |
| other | Ear pain | Ear and labyrinth disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 0 | 16 | |
| other | Hypothyroidism | Endocrine disorders | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 1 | 9 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 5 | 9 |
| Total, all-cause mortality | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 5 | 10 |
| Total, all-cause mortality | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 9 | 16 |
| Total, other adverse events | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 9 | 9 |
| Total, other adverse events | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 10 | 10 |
| Total, other adverse events | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 16 | 16 |
| Total, serious adverse events | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 2) | 3 | 9 |
| Total, serious adverse events | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Escalation - Dose Level 3) | 5 | 10 |
| Total, serious adverse events | Disulfiram, Copper, Surgery, Radiation Therapy, Temozolomide (Dose Expansion) | 7 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38768767 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02715609
GET https://conductscience.org/api/trials/v1/NCT02715609/results?page=2