Trial · NCT01038778
Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer
NCT01038778, Phase 1, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2021-02-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer. Trials, record NCT01038778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01038778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer
- NCT number
- NCT01038778
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Clear Cell Renal Cell Carcinoma, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7
- Interventions
- Aldesleukin, Computed Tomography, Entinostat, Fludeoxyglucose F-18, Laboratory Biomarker Analysis, Pharmacological Study, Positron Emission Tomography
- First posted
- 2009-12-24
- Last updated
- 2026-08-13
- Results first posted
- 2021-02-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I | 84 days | Number of dose-limiting toxicities of entinostat when combined with aldesleukin within the Phase I MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0) |
| Primary | Overall Response Rate (Complete Plus Partial) (Phase II) | Up to 12 months | The proportion of patients who have a partial or complete response to treatment evaluated by RECIST V.1.0 criteria. MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0) |
| Secondary | Incidence of Toxicity (Phase I) | 84 days | Count of participants with grade 4 toxicity. The frequency and grade of toxicities will be tabulated for each dose level. |
| Secondary | Progression-free Survival | up to 12-months after the last subject enrolls | The median progression-free survival (PFS) was estimated using standard Kaplan-Meier methods, where estimates of the median were obtained with 95% confidence intervals (CIs). PFS was defined as the time from the start of treatment to progression or death due to any cause or last follow-up, patients who did not progress or die were censored. MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0) |
| Secondary | Overall Survival | up to 12-months after the last subject enrolls | The 3-year overall survival (OS) rate was estimated using standard Kaplan-Meier methods, where estimates of the median were obtained with 95% confidence intervals (CIs). OS was defined as the time from the start of treatment to death due to any cause or last follow-up, patients who did not die were censored. |
| Secondary | Time-to-tumor Progression | up to 12-months after the last subject enrolls | The median time to tumor progression (TTP) was estimated using standard Kaplan-Meier methods, where estimates of the median were obtained with 95% confidence intervals (CIs). TTP was defined as the time from the start of treatment to progression or last follow-up. Patients that did not progress were censored. |
| Secondary | Incidence of Toxicities | Up to 30 days | The number of participants with serious adverse events. |
| Secondary | Changes in the Level of Specific T Lymphocytes | Baseline to approximately 4 weeks post-treatment, up to 1 year | Mean percent change from baseline of T lymphocytes. |
| Secondary | Changes in Tumor Metabolisms by FDG Positron Emission Tomography (PET)/Computed Tomography (CT) Scan | Baseline to approximately 5 weeks post-treatment | For binary predictors, the sensitivity and specificity with 95% confidence intervals will be reported. T tests will be used to compare the mean change between responders and non-responders. If there are sufficient numbers of responders, partial responders and non-responders an ANOVA will be used to compare changes in these three groups. If complete data are obtained for CD4+CD25\^hi T cells at multiple time points post treatment, repeated measures ANOVA will be performed to evaluate data for trends over time. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I | 84 days | All treated and eligible Phase 1 patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate (Complete Plus Partial) (Phase II) | Up to 12 months | All Phase II treated and eligible patients | Proportion of participants | NUMBER |
| SECONDARY | Incidence of Toxicity (Phase I) | 84 days | All Phase I patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | up to 12-months after the last subject enrolls | All Phase 2 patients. PFS only assessed for Phase 2. | months | MEDIAN |
| SECONDARY | Overall Survival | up to 12-months after the last subject enrolls | All Phase 2 patients. Overall Survival only assessed for Phase 2. | percentage of participants | NUMBER |
| SECONDARY | Time-to-tumor Progression | up to 12-months after the last subject enrolls | All Phase 2 patients.TTP only assessed for Phase 2. | months | MEDIAN |
| SECONDARY | Incidence of Toxicities | Up to 30 days | All Phase 2 patients. Toxicities only assessed for Phase 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in the Level of Specific T Lymphocytes | Baseline to approximately 4 weeks post-treatment, up to 1 year | All treated and evaluable patients | percentage of cells count | MEAN |
| SECONDARY | Changes in Tumor Metabolisms by FDG Positron Emission Tomography (PET)/Computed Tomography (CT) Scan | Baseline to approximately 5 weeks post-treatment | Data for this outcome was not collected. The investigator transferred from Hopkins to Roswell Park and the data for this outcome was not collected. |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I | Dose Level 1 | 0 | Participants | ||
| Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I | Dose Level 2 | 0 | Participants | ||
| Overall Response Rate (Complete Plus Partial) (Phase II) | Treatment (Entinostat, Aldesleukin) | .39 | 95% Confidence Interval .26 to .54 | Proportion of participants | |
| Incidence of Toxicity (Phase I) | Dose Level 1 | 1 | Participants | ||
| Incidence of Toxicity (Phase I) | Dose Level 2 | 0 | Participants | ||
| Progression-free Survival | Treatment (Entinostat, Aldesleukin) | 14.0 | 95% Confidence Interval 6 to NA | months | |
| Overall Survival | Treatment (Entinostat, Aldesleukin) | 82.1 | 95% Confidence Interval 62 to 93 | percentage of participants | |
| Time-to-tumor Progression | Treatment (Entinostat, Aldesleukin) | 14 | 95% Confidence Interval 6.0 to NA | months | |
| Incidence of Toxicities | Treatment (Entinostat, Aldesleukin) | 9 | Participants | ||
| Changes in the Level of Specific T Lymphocytes | Dose Level 1 | 26.3 | Standard Deviation NA | percentage of cells count |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I Dose Level 1 | 3 | |
| Overall Study | STARTED | Phase I Dose Level 2 | 8 | |
| Overall Study | STARTED | Phase 2 Dose Level 2 | 36 | |
| Overall Study | COMPLETED | Phase I Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Phase I Dose Level 2 | 6 | |
| Overall Study | COMPLETED | Phase 2 Dose Level 2 | 33 | |
| Overall Study | NOT COMPLETED | Phase I Dose Level 1 | 0 | |
| Overall Study | NOT COMPLETED | Phase I Dose Level 2 | 2 | |
| Overall Study | NOT COMPLETED | Phase 2 Dose Level 2 | 3 |
Source ClinicalTrials.gov
Adverse events404
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 | Anaemia | Blood and lymphatic system disorders | Dose Level 1 | 1 | 3 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Level 2 | 27 | 44 | 117 |
| other | Leukocytosis | Blood and lymphatic system disorders | Dose Level 1 | 0 | 3 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Dose Level 2 | 6 | 44 | 9 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Level 1 | 0 | 3 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Level 2 | 2 | 44 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Dose Level 1 | 0 | 3 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Dose Level 2 | 1 | 44 | 2 |
| other | Atrial flutter | Cardiac disorders | Dose Level 1 | 0 | 3 | 0 |
| other | Atrial flutter | Cardiac disorders | Dose Level 2 | 1 | 44 | 1 |
1 to 10 of 404Source ClinicalTrials.gov
See all 404 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 3 | 3 |
| Total, all-cause mortality | Dose Level 2 | 6 | 44 |
| Total, other adverse events | Dose Level 1 | 1 | 3 |
| Total, other adverse events | Dose Level 2 | 35 | 44 |
| Total, serious adverse events | Dose Level 1 | 0 | 3 |
| Total, serious adverse events | Dose Level 2 | 9 | 44 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants8
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 | Source |
|---|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186712 | The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network | CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186717 | Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN | DANILOV, ALEXEY V.; COLEVAS, A. DIMITRIOS; LARA, PRIMO N.; LENZ, HEINZ JOSEF | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| U01CA062505 | Phase I Molecular and Clincal Pharmacodynamic Trials | NEWMAN, EDWARD M | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA070095 | Phase I Clinical Trials of New Anti-Cancer Targeted Therapies | CARDUCCI, MICHAEL A | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
| U01CA076576 | Phase I Trials of Anti-Cancer Agents | GREVER, MICHAEL R | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1998 to 2013 | NIH RePORTER |
| R21CA137649 | Enhancing renal cell carcinoma response to IL-2 with the HDAC inhibitor SNDX-275 | CHINTALA, SREENIVASULU | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 2009 to 2010 | NIH RePORTER |
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Level 1 vs Dose Level 2: Incidence of Toxicity (Phase I) | Trial comparisons |
| Dose Level 1 vs Dose Level 2: Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I | Trial comparisons |
| Dose Level 1 vs Dose Level 2: deaths from any cause | Trial comparisons |
| Dose Level 1 vs Dose Level 2: serious adverse events | 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/NCT01038778
GET https://conductscience.org/api/trials/v1/NCT01038778/events?page=2