Trial · NCT00308165
Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors
NCT00308165, Phase 1, Completed, Columbia University; results first posted 2025-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors. Trials, record NCT00308165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00308165
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors
- NCT number
- NCT00308165
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Brain Neoplasms, Primary Malignant
- Interventions
- Convection-Enhanced Delivery, Topotecan
- First posted
- 2006-03-29
- Last updated
- 2026-06-25
- Results first posted
- 2025-06-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities | During treatment, up to 5 Days | |
| Primary | Maximum Tolerated Dose (MTD) | During treatment, up to 5 Days | If 2 participants within a cohort develop dose-limiting toxicity (DLT), the prior dose level is considered the maximum tolerated dose (MTD). Dose-Limiting Toxicities (DLT) will be defined as any new (or increased from baseline) treatment-related (drug and/or device) neurological deficits as exhibited on neurological examination with severity of grade 3 or higher. |
| Secondary | Time to Tumor Progression/Recurrence | Treatment to progression, Up to 8 years | Time to tumor progression/recurrence in weeks. |
| Secondary | Time to Death | Treatment to Time of Death, Up to 8 Years | Time to death measured in weeks |
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 | Number of Participants With Dose Limiting Toxicities | During treatment, up to 5 Days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) | During treatment, up to 5 Days | mg/ml | NUMBER | |
| SECONDARY | Time to Tumor Progression/Recurrence | Treatment to progression, Up to 8 years | 1 participant in Cohort 1 died before progression due to disease complications unrelated to treatment. 2 participants in Cohort 5 had not reached progression. These participants were excluded from the analysis. | Weeks | MEAN |
| SECONDARY | Time to Death | Treatment to Time of Death, Up to 8 Years | Death had not occurred in 1 participant in Cohort 1, 1 participant in Cohort 4, and 2 participants in Cohort 5. These participants were excluded from the analysis. | weeks | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities | Topotecan 0.02 mg/mL | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Topotecan 0.04 mg/mL | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Topotecan 0.0667 mg/mL | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Topotecan 0.1 mg/mL | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Topotecan 0.133 mg/mL | 2 | Participants | ||
| Maximum Tolerated Dose (MTD) | Topotecan | 0.1 | mg/ml | ||
| Time to Tumor Progression/Recurrence | Topotecan 0.02 mg/mL | 70.5 | Standard Deviation 74.2 | Weeks | |
| Time to Tumor Progression/Recurrence | Topotecan 0.04 mg/mL | 6.7 | Standard Deviation 2.3 | Weeks | |
| Time to Tumor Progression/Recurrence | Topotecan 0.0667 mg/mL | 31.7 | Standard Deviation 6.4 | Weeks | |
| Time to Tumor Progression/Recurrence | Topotecan 0.1 mg/mL | 36.7 | Standard Deviation 32.5 | Weeks |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Level 1: 0.02 mg/mL | STARTED | Topotecan 0.02 mg/mL | 3 | |
| Dose Level 1: 0.02 mg/mL | STARTED | Topotecan 0.04 mg/mL | 0 | |
| Dose Level 1: 0.02 mg/mL | STARTED | Topotecan 0.0667 mg/mL | 0 | |
| Dose Level 1: 0.02 mg/mL | STARTED | Topotecan 0.1 mg/mL | 0 | |
| Dose Level 1: 0.02 mg/mL | STARTED | Topotecan 0.133 mg/mL | 0 | |
| Dose Level 1: 0.02 mg/mL | COMPLETED | Topotecan 0.02 mg/mL | 3 | |
| Dose Level 1: 0.02 mg/mL | COMPLETED | Topotecan 0.04 mg/mL | 0 | |
| Dose Level 1: 0.02 mg/mL | COMPLETED | Topotecan 0.0667 mg/mL | 0 | |
| Dose Level 1: 0.02 mg/mL | COMPLETED | Topotecan 0.1 mg/mL | 0 | |
| Dose Level 1: 0.02 mg/mL | COMPLETED | Topotecan 0.133 mg/mL | 0 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 participant flowAdverse events10
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 |
|---|---|---|---|---|---|---|
| serious | Parietal syndrome | Nervous system disorders | Topotecan 0.02 mg/mL | 0 | 3 | |
| serious | Parietal syndrome | Nervous system disorders | Topotecan 0.04 mg/mL | 0 | 3 | |
| serious | Parietal syndrome | Nervous system disorders | Topotecan 0.0667 mg/mL | 0 | 3 | |
| serious | Parietal syndrome | Nervous system disorders | Topotecan 0.1 mg/mL | 0 | 3 | |
| serious | Parietal syndrome | Nervous system disorders | Topotecan 0.133 mg/mL | 1 | 4 | |
| serious | Upper extremity weakness | Nervous system disorders | Topotecan 0.02 mg/mL | 0 | 3 | |
| serious | Upper extremity weakness | Nervous system disorders | Topotecan 0.04 mg/mL | 0 | 3 | |
| serious | Upper extremity weakness | Nervous system disorders | Topotecan 0.0667 mg/mL | 0 | 3 | |
| serious | Upper extremity weakness | Nervous system disorders | Topotecan 0.1 mg/mL | 0 | 3 | |
| serious | Upper extremity weakness | Nervous system disorders | Topotecan 0.133 mg/mL | 1 | 4 |
Source ClinicalTrials.gov
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topotecan 0.02 mg/mL | 2 | 3 |
| Total, all-cause mortality | Topotecan 0.04 mg/mL | 3 | 3 |
| Total, all-cause mortality | Topotecan 0.0667 mg/mL | 3 | 3 |
| Total, all-cause mortality | Topotecan 0.1 mg/mL | 2 | 3 |
| Total, all-cause mortality | Topotecan 0.133 mg/mL | 2 | 4 |
| Total, other adverse events | Topotecan 0.02 mg/mL | 0 | 3 |
| Total, other adverse events | Topotecan 0.04 mg/mL | 0 | 3 |
| Total, other adverse events | Topotecan 0.0667 mg/mL | 0 | 3 |
| Total, other adverse events | Topotecan 0.1 mg/mL | 0 | 3 |
| Total, other adverse events | Topotecan 0.133 mg/mL | 0 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23240851 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01CA089395 | TOPOTECAN BY INTRACEREBRAL CLYSIS FOR BRAIN TUMORS | BRUCE, JEFFREY N | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL CANCER INSTITUTE | 2002 to 2006 |
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/NCT00308165
GET https://conductscience.org/api/trials/v1/NCT00308165/flow?page=2