Trial · NCT00064129
Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
NCT00064129, Phase 1, Completed, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer. Trials, record NCT00064129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00064129
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
- NCT number
- NCT00064129
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 42 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7
- Interventions
- Ipilimumab, Laboratory Biomarker Analysis, Pharmacological Study, Sargramostim
- First posted
- 2003-07-09
- Last updated
- 2020-07-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD of the combination of ipilimumab with GM-CSF that results in < 33% DLT | Continuously | Graded according to the National Cancer Institute (NCI) common toxicity criteria, version 3.0. Results will be tabulated by dose cohort and overall for this trial. DLT is defined by any of the following that are attributable to therapy: any \>= grade 4 toxicity, any ocular toxicity considered immune mediated and requiring systemic steroids, any grade 3 toxicity considered immune mediated that cannot be controlled with systemic steroids. |
| Secondary | Adaptive immunity | Baseline, days 1 and 14 of courses 1 and 2, day 1 of courses 3-6, and then day 1 of every other course throughout treatment | Measured through peripheral blood collection. Three and four-color immunofluorescence and flow cytometric analysis will be employed to determine relative numbers of activated T cells. Specifically, percentages of T cells (CD3+, CD4+ or CD8+) expressing the activation markers HLA-DR, CD25 and CD69 will be determined. Also, percentages of naive (CD45RA+) and memory (CD45RO+) T cells will be determined. |
| Secondary | PSA and/or objective response for measurable disease | Day 1 | Evaluated according to Response Evaluation Criteria in Solid Tumors (RESIST) criteria. PSA Response will be evaluated according to the recommendations from National Cancer Institute PSA Working Group. 95% confidence interval will be provided. |
| Secondary | Safety of the regimen | Continuously | Graded according to the NCI common toxicity criteria, version 3.0. |
| Secondary | Anti-idiotype antibody (human anti-human antibodies [HAHA]) development | Baseline, before each ipilimumab infusion and 2 months after the last infusion of antibody | A semi-quantitative ELISA assay will be used to detect IgG antibodies to Ipilimumab in the plasma samples. |
| Secondary | Pharmacokinetic (PK) Studies | Prior to and 60 minutes after all infusions, and at 1 and 2 months after the last ipilimumab infusion | Determined using a quantitative ELISA. |
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| P30CA082103 | Cancer Center Support Grant | ASHWORTH, ALAN | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 1999 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/NCT00064129
GET https://conductscience.org/api/trials/v1/NCT00064129/registered