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NCT01042535 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01042535: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01042535 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01042535, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This randomized phase I/II trial studies the side effects and best dose of vaccine therapy and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.
Primary Outcome
MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is
Interventions
- OTHER Laboratory biomarker analysis
- DRUG 1-methyl-d-tryptophan
- BIOLOGICAL adenovirus-p53 transduced dendritic cell (DC) vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2009-12-28 |
| Est. Completion | 2018-02-27 |
| Phase | Phase 1 |
What the finished NCT01042535 record still lists
NCT01042535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory biomarker analysis is the first listed.
NCT01042535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01042535 about?
NCT01042535 is a clinical study titled "Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer". This randomized phase I/II trial studies the side effects and best dose of vaccine therapy and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells and white blood cells may help t...
What is the current status of trial NCT01042535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2009-12-28. Estimated completion is 2018-02-27.
What interventions are being tested in trial NCT01042535?
The interventions under investigation include: Laboratory biomarker analysis (OTHER), 1-methyl-d-tryptophan (DRUG), adenovirus-p53 transduced dendritic cell (DC) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01042535?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01042535's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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