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NCT00554515 · ClinicalTrials.gov registry record · Phase 2
The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study of Metastatic Renal Cell Carcinoma, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
- 1
- Study location
NCT00554515: Completed Phase 2 study of Metastatic Renal Cell Carcinoma, sponsored by Beth Israel Deaconess Medical Center.
NCT00554515 is a Phase 2 study of Metastatic Renal Cell Carcinoma that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 123 participants, below the 140-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00554515, a Phase 2 study of Metastatic Renal Cell Carcinoma, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
- 1
- Study location
Study Summary
High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug Administration (FDA) for the treatment of metastatic kidney cancer and is a standard treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer that can produce a remission of disease that lasts after treatment is completed. However, most patients who receive IL-2 do not benefit and all patients experience potentially dangerous side effects. Recent research has suggested that certain patients may respond better to IL-2 than others. The Cytokine Working Group is currently conducting a clinical trial that aims to identify and confirm this research and narrow the application of IL-2 to those patients most likely to benefit.
Primary Outcome
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is
Conditions Studied
Interventions
- DRUG HD IL2
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2006-11 |
| Est. Completion | 2013-10-31 |
| Phase | Phase 2 |
What the finished NCT00554515 record still lists
NCT00554515 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 140-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which HD IL2 is the first listed.
NCT00554515 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00554515 about?
NCT00554515 is a clinical study titled "The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma". High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug Administration (FDA) for the treatment of metastatic kidney cancer and is a standard treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer that can produce a remission of di...
What is the current status of trial NCT00554515?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2006-11. Estimated completion is 2013-10-31.
What conditions does trial NCT00554515 study?
This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma.
What interventions are being tested in trial NCT00554515?
The interventions under investigation include: HD IL2 (DRUG).
Who is sponsoring clinical trial NCT00554515?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00554515 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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