Trial · NCT01014546
Arsenic Trioxide With or Without Ascorbic Acid in Treating Patients With Myelofibrosis
NCT01014546, Phase 1, Terminated, Roswell Park Cancer Institute
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Arsenic Trioxide With or Without Ascorbic Acid in Treating Patients With Myelofibrosis. Trials, record NCT01014546. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01014546
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Arsenic Trioxide With or Without Ascorbic Acid in Treating Patients With Myelofibrosis
- NCT number
- NCT01014546
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
- Essential Thrombocythemia, Polycythemia Vera, Primary Myelofibrosis
- Interventions
- Arsenic Trioxide, Ascorbic Acid, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2009-11-17
- Last updated
- 2022-07-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse events, and their attribution throughout the study | Up to 30 days post-treatment | The frequency of toxicities will be tabulated by grade across all dose levels and courses. The frequency of toxicities will also be tabulated for the dose chosen as the MTD. |
| Primary | Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 (Stage 1) | At 28 days | DLT is defined as any non-hematologic treatment-emergent grade 3 or greater adverse event deemed possibly, probably, or definitely related to the study drug. Exceptions are grade 3 nausea or vomiting, unless in the setting of maximal antiemetic treatment. Hematologic toxicities are not included in the definition of a DLT. The frequency of toxicities will be tabulated by grade across all dose levels and cycles. |
| Primary | Maximum tolerated dose (MTD), defined as the dose level at which 0 or 1 of 6 subjects experience DLT, and 2 of 3 or 2 of 6 experience DLT at the next higher dose level, assessed by the NCI CTC version 3.0 (Stage 1) | At 28 days | The frequency of toxicities will be tabulated by grade across all dose levels and cycles. The frequency of toxicities will also be tabulated for the dose chosen as the MTD. |
| Secondary | Change in absolute number of circulating CD34+ cells in the peripheral blood (Stage 2 only) | Baseline to 24 weeks | |
| Secondary | Change in JAK2/MPL (Stage 2 only) | Baseline to 24 weeks | |
| Secondary | Change in plasma levels of chemokines as measured by ELISA (Stage 2) | Baseline to 24 weeks | Including: sVCAM-1, NE, MMP-2, MMP-9, SDF-1, TGF-B, and VEGF. |
| Secondary | Change in plasma levels of cytokines as measured by ELISA (Stage 2) | Baseline to 24 weeks | Including: sVCAM-1, NE, MMP-2, MMP-9, SDF-1, TGF-B, and VEGF. |
| Secondary | Change in plasma levels of proteases as measured by enzyme-linked immunosorbent assay (ELISA) (Stage 2) | Baseline to 24 weeks | Including: soluble vascular cell adhesion molecule 1 (sVCAM-1), neutrophil elastase (NE), matrix metalloproteinases 2 and 9 (MMP-2 and MMP-9), stromal cell derived growth factor-1 (SDF-1), TGF-B, and VEGF. |
| Secondary | Disease response assessed using the IWG-MRT response criteria | Up to 24 weeks |
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.
Papers0
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 |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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/NCT01014546
GET https://conductscience.org/api/trials/v1/NCT01014546/registered