Trial · NCT01903330
ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme
NCT01903330, Phase 2, Unknown, Epitopoietic Research Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme. Trials, record NCT01903330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01903330
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme
- NCT number
- NCT01903330
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 84 participants, estimated
- Lead sponsor
- Epitopoietic Research Corporation
- Conditions
- Glioblastoma, Gliosarcoma
- Interventions
- ERC1671, GM-CSF, Cyclophosphamide, Oral Control (Sucrose pill), Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%)), Bevacizumab/Bevacizumab Biosimilar
- First posted
- 2013-07-19
- Last updated
- 2025-03-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival at 12 months of patients with recurrent, bevacizumab naïve glioblastoma treated with ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab as compared with patients receiving bevacizumab plus placebo controls. | 12 months | To evaluate overall survival in patients with with recurrent, bevacizumab naïve glioblastoma treated with ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab as compared with patients receiving bevacizumab plus placebo controls. |
| Secondary | Rate of Progression-Free Survival | 12 months | Progression-free survival will be defined as the time from Day 1 to the date of progression or death due to any cause. |
| Secondary | Immune Response | 12 months | The patient's immune response evaluation will include cytotoxic T lymphocytes (CTL) (CD3+/cluster of differentiation (CD)8+) and Treg (CD3+/CD4+/cluster of differentiation 25+ (CD25+)/CD127low) populations where CD refers to cluster of differentiation. Cytokine analyses should initially be limited to IFN-ɣ, TNF and IL-6. Further immune studies should include transforming growth factor (TGF)-B2, IL-12, IL-10. |
| Secondary | Percentage of Grade 3-5 Adverse Events | 12 months | Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Safety will also be assessed by clinical laboratory tests, physical examinations, vital sign measurements and the incidence and severity of adverse events (AEs). |
| Secondary | Rate of Radiographic Response as assessed using MacDonald Criteria or IRANO | 12 month | Patients will be followed both clinically and radiographically every 6 weeks for evidence of tumor progression. Tumor response will be assessed using the MacDonald Criteria or iRANO, Immunotherapy Response Assessment in Neuro-Oncology. iRANO/MacDonald CRITERIA: * Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan. * Partial response (PR): Greater than or equal to a 50% reduction in the size (sum of products of the largest diameter, SPD) for all enhancing lesions. * Stable Disease (SD): SPD \<50% decrease to \<25% increase, does not qualify for CR, PR, or progression. * Progressive Disease (PD): Greater than or equal to a 25% increase in SPD. * Unable to Assess (UA): Some target lesions cannot be evaluated because of technical factors. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25865468 | 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/NCT01903330
GET https://conductscience.org/api/trials/v1/NCT01903330/registered