Trial · NCT00085540
FR901228 in Treating Patients With Recurrent High-Grade Gliomas
NCT00085540, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FR901228 in Treating Patients With Recurrent High-Grade Gliomas. Trials, record NCT00085540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085540
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FR901228 in Treating Patients With Recurrent High-Grade Gliomas
- NCT number
- NCT00085540
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Interventions
- depsipeptide
- First posted
- 2004-06-11
- Last updated
- 2017-01-02
- Results first posted
- 2016-11-15
- Limitations and caveats
Dose escalation was terminated after 2 dose levels because PK parameters of romidepsin in pts receiving EIAEDs were similar to those reported in Adults not receiving CYP34A inducing drugs, we wanted to avoid the expected dose limiting toxicity.
Source ClinicalTrials.gov
Registered outcomes3
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 Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I) | First 4 weeks of treatment | dose limiting toxicity defined as: ANC \</=1000 or Platelets \<100K; SGOT \>/= 3X ULN and T. Bili \>/= 1.5 ULN grade 3 Nausea, vomiting, fatigue and asymptomatic hypocalcemia (treatment may continue after discuss with PI) |
| Primary | 6 Months Progression-free Survival (Phase II) | At 6 months | evaluated patients with glioblastoma (GBM (35 patients) |
| Secondary | Response Rate Associated With Depsipeptide Therapy (Phase II) | Up to 2 years | RECIST Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids. Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition |
Source ClinicalTrials.gov
Outcomes3
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 Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I) | First 4 weeks of treatment | participants | NUMBER | |
| PRIMARY | 6 Months Progression-free Survival (Phase II) | At 6 months | evaluation of patients with GBM histology | percentage of participants | NUMBER |
| SECONDARY | Response Rate Associated With Depsipeptide Therapy (Phase II) | Up to 2 years | GBM patients - no responses | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
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 Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I) | Phase 1 Dose Escalation - Romidepsin | 0 | participants | ||
| 6 Months Progression-free Survival (Phase II) | Phase 2 Dose From Phase 1 - Romidepsin | 3 | percentage of participants | ||
| Response Rate Associated With Depsipeptide Therapy (Phase II) | Phase 2 Dose From Phase 1 - Romidepsin | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 Dose Escalation - Romidepsin | 8 | |
| Overall Study | STARTED | Phase 2 Dose From Phase 1 - Romidepsin | 42 | |
| Overall Study | COMPLETED | Phase 1 Dose Escalation - Romidepsin | 8 | |
| Overall Study | COMPLETED | Phase 2 Dose From Phase 1 - Romidepsin | 40 | |
| Overall Study | NOT COMPLETED | Phase 1 Dose Escalation - Romidepsin | 0 | |
| Overall Study | NOT COMPLETED | Phase 2 Dose From Phase 1 - Romidepsin | 2 |
Source ClinicalTrials.gov
Adverse events58
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 | Phase 1 Dose Escalation - Romidepsin | 3 | 8 | 3 |
| other | anemia | Blood and lymphatic system disorders | Phase 2 Dose From Phase 1 - Romidepsin | 8 | 40 | 8 |
| other | Leucopenia | Blood and lymphatic system disorders | Phase 1 Dose Escalation - Romidepsin | 3 | 8 | 3 |
| other | Leucopenia | Blood and lymphatic system disorders | Phase 2 Dose From Phase 1 - Romidepsin | 8 | 40 | 8 |
| other | neutropenia | Blood and lymphatic system disorders | Phase 1 Dose Escalation - Romidepsin | 3 | 8 | 3 |
| other | neutropenia | Blood and lymphatic system disorders | Phase 2 Dose From Phase 1 - Romidepsin | 7 | 40 | 7 |
| other | lymphopenia | Investigations | Phase 1 Dose Escalation - Romidepsin | 1 | 8 | 1 |
| other | lymphopenia | Investigations | Phase 2 Dose From Phase 1 - Romidepsin | 9 | 40 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1 Dose Escalation - Romidepsin | 6 | 8 | 6 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 2 Dose From Phase 1 - Romidepsin | 15 | 40 | 15 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Dose Escalation - Romidepsin | ||
| Total, all-cause mortality | Phase 2 Dose From Phase 1 - Romidepsin | ||
| Total, other adverse events | Phase 1 Dose Escalation - Romidepsin | 8 | 8 |
| Total, other adverse events | Phase 2 Dose From Phase 1 - Romidepsin | 40 | 40 |
| Total, serious adverse events | Phase 1 Dose Escalation - Romidepsin | 0 | 8 |
| Total, serious adverse events | Phase 2 Dose From Phase 1 - Romidepsin | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21377994 | 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 |
|---|---|---|---|---|---|
| U01CA062399 | NABTC Central Operation Grant (UCSF Project Leader) | PRADOS, MICHAEL D | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 1994 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase 1 Dose Escalation - Romidepsin vs Phase 2 Dose From Phase 1 - Romidepsin: serious adverse events |
Source Trial comparisons
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/NCT00085540
GET https://conductscience.org/api/trials/v1/NCT00085540/events?page=2