Trial · NCT01836549
Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors
NCT01836549, Phase 2, Terminated, Pediatric Brain Tumor Consortium; results first posted 2018-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors. Trials, record NCT01836549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01836549
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors
- NCT number
- NCT01836549
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Pediatric Brain Tumor Consortium
- Conditions
- Anaplastic Astrocytoma, Anaplastic Ependymoma, Astrocytoma, Grade II, Ependymoma, Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma, Oligodendroglioma, Brainstem Tumors
- Interventions
- imetelstat sodium
- First posted
- 2013-04-22
- Last updated
- 2018-07-20
- Results first posted
- 2018-07-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numver of Patients With Telomerase-positive Archival Tumors Who Demonstrate at Least 50% Reduction | Up to 30 days | This outcome measure is for the Molecular biology study only. The assessment was done to identify cases with at least 50% reduction in telomerase activity. |
| Primary | Phase II: Stratum-specific Objective Response (CR+PR) Rate | 6 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR sustained for at least 6 weeks. For each stratum separately exact confidence interval estimates will be provided for the true, unknown rates of objective response. Estimated by cumulative incidence functions. |
| Secondary | Number of Participants With Telomerase Inhibition | Up to 30 days | This outcome measure is applicable only for the Molecular biology study arm. Telomerase inhibition was assessed in PBMCs and summarised as 'yes-inhibited' vs. 'no inhibition' |
| Secondary | Stratum-specific Progression-free Survival (PFS) (Phase II) | Up to 2 years, from the date of initial treatment to the earliest date of disease progression, second malignancy or death for subjects who fail; and to the date of last contact for subjects who remain at risk for failure, assessed up to 3 years | Kaplan-Meier estimates of distributions of survival and PFS for all eligible subjects who received at least one dose of imetelstat will be provided separately. |
| Secondary | Number of Patients With Telomerase Expression Data by Detection of hTERT mRNA and TERC RNA Levels by qRT-PCR and Telomerase Activity by TRAP in Archival Tumor Tissue and to Explore Association of Telomerase Positivity With Objective Response and PFS | Up to 30 days. Due to small number of patients evaluable for this objective, we can only provide number of patients with the targetted markers as no analysis with PFS is possible. | This secondary objective is for Stratum-B and C only, which enroll HGG and ependymoma patients. We will describe the evidence of telomerase expression by detection of hTERT mRNA and TERC RNA levels by qRT-PCR and telomerase activity by TRAP in archival tumor tissue; Association of telomerase positivity with objective response and PFS will not be able to be conducted as the study was terminated early and there was no objective response. |
| Secondary | Quantitative MRI Parameters of Tumors Prior to and After Treatment With Imetelstat (Molecular Biology and Phase II Studies) | Up to 30 days | This outcome measure was for both Molecular biology and Phase II studies. We will not be able to present the results of this objective as the study was terminated early. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numver of Patients With Telomerase-positive Archival Tumors Who Demonstrate at Least 50% Reduction | Up to 30 days | This outcome measure is only for the molecular biology study. Telomerase inhibition was assessed and the inhibition level was compared with the baseline level to identify increased inhibition. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase II: Stratum-specific Objective Response (CR+PR) Rate | 6 months | This is the Phase-II study cohort, excluding the molecular study patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Telomerase Inhibition | Up to 30 days | Samples from six patients were consequently considered evaluable and were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Stratum-specific Progression-free Survival (PFS) (Phase II) | Up to 2 years, from the date of initial treatment to the earliest date of disease progression, second malignancy or death for subjects who fail; and to the date of last contact for subjects who remain at risk for failure, assessed up to 3 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | days | MEAN |
| SECONDARY | Number of Patients With Telomerase Expression Data by Detection of hTERT mRNA and TERC RNA Levels by qRT-PCR and Telomerase Activity by TRAP in Archival Tumor Tissue and to Explore Association of Telomerase Positivity With Objective Response and PFS | Up to 30 days. Due to small number of patients evaluable for this objective, we can only provide number of patients with the targetted markers as no analysis with PFS is possible. | This objective is for STRATUM-C patients only, having only 4 patients with TRAP, TERT and TERC levels measured. Due to small sample and having no objective response, association studies of these markers with Objective Reponse and PFS were not possible. Therefore, we only report the the percentage of cases with at least weak TRAP activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quantitative MRI Parameters of Tumors Prior to and After Treatment With Imetelstat (Molecular Biology and Phase II Studies) | Up to 30 days | This study has been terminated early and the study team decided not to pursue this aim as the results would be inconclusive due to small sample size. Neither the neuroimaging, nor the biology data are available for these patients. |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numver of Patients With Telomerase-positive Archival Tumors Who Demonstrate at Least 50% Reduction | Molecular Biology Study | 1 | Participants | ||
| Phase II: Stratum-specific Objective Response (CR+PR) Rate | Stratum-A | 0 | Participants | ||
| Phase II: Stratum-specific Objective Response (CR+PR) Rate | Stratum-B | 0 | Participants | ||
| Phase II: Stratum-specific Objective Response (CR+PR) Rate | Stratum-C | 0 | Participants | ||
| Phase II: Stratum-specific Objective Response (CR+PR) Rate | Stratum-D | 0 | Participants | ||
| Number of Participants With Telomerase Inhibition | Molecular Biology Study | 5 | Participants | ||
| Stratum-specific Progression-free Survival (PFS) (Phase II) | Stratum-A | 30 | Standard Error 3.06 | days | |
| Stratum-specific Progression-free Survival (PFS) (Phase II) | Stratum-B | 54.2 | Standard Error 9.97 | days | |
| Stratum-specific Progression-free Survival (PFS) (Phase II) | Stratum-C | 50.3 | Standard Error 16.25 | days | |
| Stratum-specific Progression-free Survival (PFS) (Phase II) | Stratum-D | 52.6 | Standard Error 14.50 | days |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Molecular Biology Stratum-A | 1 | |
| Overall Study | STARTED | Molecular Biology Stratum-B | 1 | |
| Overall Study | STARTED | Molecular Biology Stratum-C | 1 | |
| Overall Study | STARTED | Stratum-A | 9 | |
| Overall Study | STARTED | Stratum-B | 18 | |
| Overall Study | STARTED | Stratum-C | 4 | |
| Overall Study | STARTED | Stratum-D | 9 | |
| Overall Study | COMPLETED | Molecular Biology Stratum-A | 1 | |
| Overall Study | COMPLETED | Molecular Biology Stratum-B | 1 | |
| Overall Study | COMPLETED | Molecular Biology Stratum-C | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events624
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 | Molecular Study-A | 1 | 1 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Molecular Study-B | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Stratum-A | 4 | 8 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Stratum-B | 7 | 18 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Stratum-C | 2 | 4 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Stratum-D | 0 | 8 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Molecular Study-A | 0 | 1 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Molecular Study-B | 0 | 1 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Stratum-A | 0 | 8 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Stratum-B | 0 | 18 | 0 |
1 to 10 of 624Source ClinicalTrials.gov
See all 624 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Molecular Study-A | ||
| Total, all-cause mortality | Molecular Study-B | ||
| Total, all-cause mortality | Stratum-A | ||
| Total, all-cause mortality | Stratum-B | ||
| Total, all-cause mortality | Stratum-C | ||
| Total, all-cause mortality | Stratum-D | ||
| Total, other adverse events | Molecular Study-A | 1 | 1 |
| Total, other adverse events | Molecular Study-B | 1 | 1 |
| Total, other adverse events | Stratum-A | 8 | 8 |
| Total, other adverse events | Stratum-B | 16 | 18 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| U01CA081457 | Pediatric Brain Tumor Consortium (PBTC) | BOYETT, JAMES MILFORD | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1999 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/NCT01836549
GET https://conductscience.org/api/trials/v1/NCT01836549/flow?page=2