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NCT00064129 · ClinicalTrials.gov registry record · Phase 1
Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00064129: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00064129 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064129, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of ipilimumab when given with sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system kill more tumor cells.
Primary Outcome
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.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Sargramostim
- OTHER Pharmacological Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2003-05-13 |
| Est. Completion | 2012-10-01 |
| Phase | Phase 1 |
What the finished NCT00064129 record still lists
NCT00064129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00064129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00064129 about?
NCT00064129 is a clinical study titled "Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer". This phase I trial is studying the side effects and best dose of ipilimumab when given with sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. C...
What is the current status of trial NCT00064129?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2003-05-13. Estimated completion is 2012-10-01.
What interventions are being tested in trial NCT00064129?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Ipilimumab (BIOLOGICAL), Sargramostim (BIOLOGICAL), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT00064129?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00064129's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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