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NCT00314093 · ClinicalTrials.gov registry record · Phase 2
RFT-5-dgA in Patients With Metastatic Melanoma
A Phase 2 study of Metastatic Melanoma, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT00314093: Completed Phase 2 study of Metastatic Melanoma, sponsored by University of Texas Southwestern Medical Center.
NCT00314093 is a Phase 2 study of Metastatic Melanoma that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 41 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00314093, a Phase 2 study of Metastatic Melanoma, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * CD4+ cells are white blood cells that regulate the immune system by controlling the strength and quality of the immune response. * CD25+ cells are a subset of CD4+ cells that suppress or prevent immune responses. * RFT-5-dgA is an immunotoxin (substance that kills specific cells in the immune system) that kills CD25+ cells. * In mouse studies, RFT-5-dgA showed anti-tumor activity in animals studies. Objective: To determine whether the immune system of patients with metastatic melanoma (melanoma that has spread beyond the original site) can cause tumors to shrink if the patients are given RFT-5-dgA to remove their CD25+ cells. Eligibility: Patients 18 years of age and older with metastatic melanoma whose disease has progressed after receiving standard treatment. Design: * Patients receive RFT-5-dgA through a vein every other day for a total of 3 doses (one treatment course). Patients have routine blood tests during the week of treatment. * Four to 5 weeks after the last dose, patients are evaluated with a physical examination, blood tests and scans and x-rays to evaluate their tumor. * Patients whose tumor has shrunk or remained stable may be offered additional treatment with RFT-5-dgA up to a total of four courses. * Patients undergo leukapheresis or have several tubes of blood drawn from a vein to determine the effects of RFT-5-dgA on the immune system. This is done before the first dose of RFT-5-dgA, after the first three doses, and possibly during subsequent treatment courses in those patients who receive additional treatment. For leukapheresis, blood is collected through a needle in an arm vein and flows through a catheter into a machine that separates it into its components by spinning. The white cells are extracted and the rest of the blood is returned through another needle in the other arm.
Primary Outcome
The primary objective is to determine whether objective clinical responses can be obtained in patients with metastatic melanoma following administration of RFT5-dgA
Conditions Studied
Interventions
- DRUG RFT5pdgA
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
What the finished NCT00314093 record still lists
NCT00314093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 1 intervention - of which RFT5pdgA is the first listed.
NCT00314093 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00314093 about?
NCT00314093 is a clinical study titled "RFT-5-dgA in Patients With Metastatic Melanoma". Background: * CD4+ cells are white blood cells that regulate the immune system by controlling the strength and quality of the immune response. * CD25+ cells are a subset of CD4+ cells that suppress or prevent immune responses. * RFT-5-dgA is an immunotoxin (substance that kills specific cells in th...
What is the current status of trial NCT00314093?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2006-04. Estimated completion is 2008-11.
What conditions does trial NCT00314093 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT00314093?
The interventions under investigation include: RFT5pdgA (DRUG).
Who is sponsoring clinical trial NCT00314093?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00314093 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00314093's enrollment target sits among peer trials
41 43rd of 91 higher than 49 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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.
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