Trial · NCT00643097
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00643097, Phase 2, Completed, John Sampson; results first posted 2014-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Trials, record NCT00643097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00643097
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- NCT number
- NCT00643097
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- John Sampson
- Conditions
- Malignant Neoplasms of Brain
- Interventions
- PEP-3 vaccine, sargramostim, Temozolomide
- First posted
- 2008-03-26
- Last updated
- 2017-02-01
- Results first posted
- 2014-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Humoral and Cellular Immune Response | 26 months | Number of patients that developed a delayed-type hypersensitivity (DTH) response at following vaccination. Any skin reaction in response to the intradermal injection of the antigen was measured and recorded. A positive skin test was defined as \> 5 mm induration (swelling). |
| Primary | Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS) | 58 months | Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator). |
| Secondary | Response to Vaccination | 26 months | The objective is to assess the duration of immunosuppressive cytokine secretion and to identify a receptive interval for active immunotherapy. Immunosuppression will determined by monitoring a panel of immunosuppressive serum/plasma cytokines longitudinally and by determining the response of each patient to Recombivax Hepatitis B (HB) vaccination. Response is defined as seropositive or seronegative to the Hepatitis B surface antigen. |
| Secondary | Toxicity to PEP-3 Vaccine Immunization | 26 months | To assess for any potential toxicity to the PEP-3 vaccine immunization in patients with newly diagnosed glioblastoma, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to tabulate any toxicities attributable to PEP-3. The number of patients with toxicity attributable to vaccine while on study are tabulated. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Humoral and Cellular Immune Response | 26 months | The test was performed on a subset of patients in each group that were available at vaccine 8, and results posted for those 30 patients who had the tests performed. | participants | NUMBER |
| PRIMARY | Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS) | 58 months | months | MEDIAN | |
| SECONDARY | Response to Vaccination | 26 months | This objective was not completed, as the test was not performed successfully. | Months | MEAN |
| SECONDARY | Toxicity to PEP-3 Vaccine Immunization | 26 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Humoral and Cellular Immune Response | Arm I (ACTIVATE) | 3 | participants | ||
| Humoral and Cellular Immune Response | Arm II (ACT II STD) | 0 | participants | ||
| Humoral and Cellular Immune Response | Arm III (ACT II DI) | 7 | participants | ||
| Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS) | Arm I (ACTIVATE) | 14.2 | 95% Confidence Interval 9.9 to 17.6 | months | |
| Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS) | Arm II (ACT II STD) | 12.1 | 95% Confidence Interval 10.5 to 23.7 | months | |
| Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS) | Arm III (ACT II DI) | 11.6 | 95% Confidence Interval 8.1 to 12.7 | months | |
| Response to Vaccination | Arm I (ACTIVATE) | NA | Standard Deviation NA | Months | |
| Response to Vaccination | Arm II (ACT II STD) | NA | Standard Deviation NA | Months | |
| Response to Vaccination | Arm III (ACT II DI) | NA | Standard Deviation NA | Months | |
| Toxicity to PEP-3 Vaccine Immunization | Arm I (ACTIVATE) | 4 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (ACTIVATE) | 18 | |
| Overall Study | STARTED | Arm II (ACT II STD) | 12 | |
| Overall Study | STARTED | Arm III (ACT II DI) | 10 | |
| Overall Study | COMPLETED | Arm I (ACTIVATE) | 18 | |
| Overall Study | COMPLETED | Arm II (ACT II STD) | 12 | |
| Overall Study | COMPLETED | Arm III (ACT II DI) | 10 | |
| Overall Study | NOT COMPLETED | Arm I (ACTIVATE) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (ACT II STD) | 0 | |
| Overall Study | NOT COMPLETED | Arm III (ACT II DI) | 0 |
Source ClinicalTrials.gov
Adverse events318
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 | Ear and labyrinth disorders - Other, specify: Ear Fullness - not infection | Ear and labyrinth disorders | Arm I (ACTIVATE) | 0 | 18 | |
| other | Ear and labyrinth disorders - Other, specify: Ear Fullness - not infection | Ear and labyrinth disorders | Arm II (ACT II STD) | 0 | 12 | |
| other | Ear and labyrinth disorders - Other, specify: Ear Fullness - not infection | Ear and labyrinth disorders | Arm III (ACT II DI) | 1 | 10 | |
| other | Ear and labyrinth disorders - Other, specify: Left ear fluid | Ear and labyrinth disorders | Arm I (ACTIVATE) | 1 | 18 | |
| other | Ear and labyrinth disorders - Other, specify: Left ear fluid | Ear and labyrinth disorders | Arm II (ACT II STD) | 0 | 12 | |
| other | Ear and labyrinth disorders - Other, specify: Left ear fluid | Ear and labyrinth disorders | Arm III (ACT II DI) | 0 | 10 | |
| other | External ear inflammation | Ear and labyrinth disorders | Arm I (ACTIVATE) | 0 | 18 | |
| other | External ear inflammation | Ear and labyrinth disorders | Arm II (ACT II STD) | 1 | 12 | |
| other | External ear inflammation | Ear and labyrinth disorders | Arm III (ACT II DI) | 0 | 10 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm I (ACTIVATE) | 0 | 18 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (ACTIVATE) | ||
| Total, all-cause mortality | Arm II (ACT II STD) | ||
| Total, all-cause mortality | Arm III (ACT II DI) | ||
| Total, other adverse events | Arm I (ACTIVATE) | 17 | 18 |
| Total, other adverse events | Arm II (ACT II STD) | 12 | 12 |
| Total, other adverse events | Arm III (ACT II DI) | 9 | 10 |
| Total, serious adverse events | Arm I (ACTIVATE) | 1 | 18 |
| Total, serious adverse events | Arm II (ACT II STD) | 0 | 12 |
| Total, serious adverse events | Arm III (ACT II DI) | 3 | 10 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50NS020023 | SRC on Primary Tumors of the CNS | BIGNER, DARELL D | DUKE UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 1985 to 2013 |
Source NIH RePORTER
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/NCT00643097
GET https://conductscience.org/api/trials/v1/NCT00643097/events?page=2