Trial · NCT00400517
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
NCT00400517, Phase 2, Completed, The Cleveland Clinic; results first posted 2018-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer. Trials, record NCT00400517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00400517
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
- NCT number
- NCT00400517
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Prostate Cancer
- Interventions
- sargramostim, thalidomide, conventional surgery, neoadjuvant therapy
- First posted
- 2006-11-17
- Last updated
- 2018-08-28
- Results first posted
- 2018-08-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients P0 at Surgery | 8 weeks | Pathologic Complete Response is defined as complete eradication of tumor. |
| Primary | Proportion of Patients With Negative Surgical Margins | 8 Weeks | Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy. |
| Primary | Prostate-specific Antigen Response | 8 weeks | Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry. |
| Primary | Time to Clinical Progression | 32 months | Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure. |
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 | Proportion of Patients P0 at Surgery | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Proportion of Patients With Negative Surgical Margins | 8 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Prostate-specific Antigen Response | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Time to Clinical Progression | 32 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients P0 at Surgery | GM-CSF Injections and Oral Thalidomide | 0 | Participants | ||
| Proportion of Patients With Negative Surgical Margins | GM-CSF Injections and Oral Thalidomide | 0 | Participants | ||
| Prostate-specific Antigen Response | GM-CSF Injections and Oral Thalidomide | 22 | Participants | ||
| Time to Clinical Progression | GM-CSF Injections and Oral Thalidomide | 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 | GM-CSF Injections and Oral Thalidomide | 28 | |
| Overall Study | COMPLETED | GM-CSF Injections and Oral Thalidomide | 26 | |
| Overall Study | NOT COMPLETED | GM-CSF Injections and Oral Thalidomide | 2 |
Source ClinicalTrials.gov
Adverse events8
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 | Constipation | Gastrointestinal disorders | GM-CSF Injections and Oral Thalidomide | 17 | 27 | |
| other | Injection Site Reaction | Skin and subcutaneous tissue disorders | GM-CSF Injections and Oral Thalidomide | 15 | 27 | |
| other | Peripheral Neropathy | Nervous system disorders | GM-CSF Injections and Oral Thalidomide | 7 | 27 | |
| other | Fatigue | General disorders | GM-CSF Injections and Oral Thalidomide | 12 | 27 | |
| other | Solmnolene/Dizziness | General disorders | GM-CSF Injections and Oral Thalidomide | 9 | 27 | |
| serious | Injection Site Reaction | Skin and subcutaneous tissue disorders | GM-CSF Injections and Oral Thalidomide | 1 | 27 | |
| serious | Urticaria | Skin and subcutaneous tissue disorders | GM-CSF Injections and Oral Thalidomide | 1 | 27 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | GM-CSF Injections and Oral Thalidomide | 1 | 27 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GM-CSF Injections and Oral Thalidomide | ||
| Total, other adverse events | GM-CSF Injections and Oral Thalidomide | 27 | 27 |
| Total, serious adverse events | GM-CSF Injections and Oral Thalidomide | 3 | 27 |
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/NCT00400517
GET https://conductscience.org/api/trials/v1/NCT00400517/registered