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NCT00070070 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00070070: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT00070070 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00070070, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as Bacille Calmette Guerin (BCG) and sargramostim (GM-CSF), use different ways to stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving vaccine therapy together with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell carcinomas.
Primary Outcome
All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTCAE) (Version 3.0). A Dose limiting toxicity (DLT) was defined as: * ≥ Grade 2 autoimmune phenomena * Asymptomatic bronchospasm or generalized urticaria * ≥ Grade 3 hematological and non hematological toxicities. To be dose limiting, an adverse event must have been definitely, probably, or possibly related to the administration of the study treatment. Patients who experienced a DLT were removed
Interventions
- BIOLOGICAL sargramostim
- BIOLOGICAL NY-ESO-1 protein
- BIOLOGICAL TICE®-strain BCG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2003-10-28 |
| Est. Completion | 2013-09-30 |
| Phase | Phase 1 |
What the finished NCT00070070 record still lists
NCT00070070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which sargramostim is the first listed.
NCT00070070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00070070 about?
NCT00070070 is a clinical study titled "Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas". RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as Bacille Calmette Guerin (BCG) and sargramostim (GM-CSF), use different ways to stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy...
What is the current status of trial NCT00070070?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2003-10-28. Estimated completion is 2013-09-30.
What interventions are being tested in trial NCT00070070?
The interventions under investigation include: sargramostim (BIOLOGICAL), NY-ESO-1 protein (BIOLOGICAL), TICE®-strain BCG (BIOLOGICAL).
Who is sponsoring clinical trial NCT00070070?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00070070's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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