Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00913913 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients
A Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00913913 is a Phase 2 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 8 participants.
The verdict
NCT00913913, a Phase 2 study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Immune therapies, such as a IL-2, for metastatic renal cell carcinoma (mRCC) are designed to mobilize immune effector cells that recognize and destroy cancer. The investigators have recently observed a 50% objective response rate (16% CR) in mRCC patients treated with autologous tumor lysate -dendritic cell (DC)-vaccine, IL-2 and interferon alfa (IFN). New agents inhibiting vascular endothelial growth factor (VEGF) pathways have demonstrated significant benefit in mRCC patients as well, but rarely induce CRs. High blood VEGF is associated with poor response to IL-2 and can cause tumor specific immune dysregulation. To test whether complementary mechanisms of immune activation and disruption of regulatory pathways enhance outcome the investigators plan to treat 24 mRCC patients in a phase II trial using bevacizumab, DC vaccine, IL-2, and IFN. Observations from this project will be used in the development of novel cancer therapies which, if successful, will decrease the burden of cancer on the public. The investigators propose to determine 1) the objective clinical response rate to treatment and progression free survival, 2) the clinical and autoimmune related toxicity profile of therapy, and 3) the treatment related tumor-specific immune response and the relationship of tumor-specific immune response and objective clinical response.
Interventions
- DRUG Bevacizumab
- BIOLOGICAL IL-2
- BIOLOGICAL DC vaccine
- BIOLOGICAL IFN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00913913
The ClinicalTrials.gov registry entry for NCT00913913 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00913913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00913913 about?
NCT00913913 is a clinical study titled "Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients". Immune therapies, such as a IL-2, for metastatic renal cell carcinoma (mRCC) are designed to mobilize immune effector cells that recognize and destroy cancer. The investigators have recently observed a 50% objective response rate (16% CR) in mRCC patients treated with autologous tumor lysate -dendri...
What is the current status of trial NCT00913913?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2009-02. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00913913?
The interventions under investigation include: Bevacizumab (DRUG), IL-2 (BIOLOGICAL), DC vaccine (BIOLOGICAL), IFN (BIOLOGICAL).
Who is sponsoring clinical trial NCT00913913?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.