Trial · NCT00939510
Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
NCT00939510, Phase 1, Phase 2, Completed, Robert Dreicer MD; results first posted 2012-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer. Trials, record NCT00939510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00939510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
- NCT number
- NCT00939510
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Robert Dreicer MD
- Conditions
- Prostate Cancer
- Interventions
- sargramostim, lenalidomide, laboratory biomarker analysis
- First posted
- 2009-07-15
- Last updated
- 2013-01-31
- Results first posted
- 2012-07-12
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 Patients With a PSA Response | reevaluated for response every eight weeks | Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value. |
| Primary | RECIST-defined Measurable Disease | every 8 weeks and at end of treatment | Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks |
| Secondary | Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study | every 28 days for first 3 cycles, end of study | The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques. |
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 Patients With a PSA Response | reevaluated for response every eight weeks | All patients that received treatment. | participants | NUMBER |
| SECONDARY | Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study | every 28 days for first 3 cycles, end of study | All patients that received treatment | participants | NUMBER |
| PRIMARY | RECIST-defined Measurable Disease | every 8 weeks and at end of treatment | 12 patients had RECIST-defined measurable disease. One patient came off study early for toxicity and therefore was not evaluable. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With a PSA Response | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | PSA response | 4 | participants | |
| Number of Patients With a PSA Response | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | PSA no response | 27 | participants | |
| Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 0 | participants | ||
| RECIST-defined Measurable Disease | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | Number of patients with stable disease (SD) | 4 | participants | |
| RECIST-defined Measurable Disease | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | Number of patients with partial response (PR) | 2 | participants | |
| RECIST-defined Measurable Disease | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | Number of patients with progressive disease | 5 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 32 | |
| Overall Study | COMPLETED | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 31 | |
| Overall Study | NOT COMPLETED | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 1 |
Source ClinicalTrials.gov
Adverse events18
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 | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 15 | 31 | |
| other | Constipation | Gastrointestinal disorders | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 10 | 31 | |
| other | Diarrhea | Gastrointestinal disorders | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 9 | 31 | |
| other | Elevated Lactate dehydrogenase (LDH) | Investigations | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 5 | 31 | |
| other | Fatigue | General disorders | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 22 | 31 | |
| other | Hypocalcemia | Metabolism and nutrition disorders | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 7 | 31 | |
| other | Injection site reactions | General disorders | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 17 | 31 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 11 | 31 | |
| other | Lymphopenia | Investigations | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 12 | 31 | |
| other | Nausea/Vomiting | Gastrointestinal disorders | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 11 | 31 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | ||
| Total, other adverse events | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 31 | 31 |
| Total, serious adverse events | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | 5 | 31 |
Source ClinicalTrials.gov
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 |
|---|---|---|---|---|---|
| P30CA043703 | Case Comprehensive Cancer Center Support Grant | SCHWARTZ, GARY K | CASE WESTERN RESERVE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1987 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/NCT00939510
GET https://conductscience.org/api/trials/v1/NCT00939510/registered