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NCT00512798 · ClinicalTrials.gov registry record · Phase 1
Bortezomib and Temozolomide in Treating Patients With Advanced Refractory Solid Tumors or Melanoma
A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT00512798: Clinical Trial Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT00512798 is a Phase 1 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00512798, a Phase 1 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temozolomide together with bortezomib may kill more tumor cells. PURPOSE: To determine the best dose of bortezomib and temozolomide and to see how well they work in treating patients with advanced refractory solid tumors or melanoma.
Primary Outcome
The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide
Interventions
- DRUG Temozolomide
- DRUG temozolomide
- OTHER immunoenzyme technique
- DRUG PS-341 (VELCADE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2003-06 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
Why NCT00512798 stopped before completion
NCT00512798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT00512798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00512798 about?
NCT00512798 is a clinical study titled "Bortezomib and Temozolomide in Treating Patients With Advanced Refractory Solid Tumors or Melanoma". RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temozolomide togethe...
What is the current status of trial NCT00512798?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2003-06. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00512798?
The interventions under investigation include: Temozolomide (DRUG), temozolomide (DRUG), immunoenzyme technique (OTHER), PS-341 (VELCADE) (DRUG).
Who is sponsoring clinical trial NCT00512798?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00512798's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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