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NCT00077922 · ClinicalTrials.gov registry record · Phase 2
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00077922: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00077922 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00077922, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating chronic lymphocytic leukemia (CLL) in patients who have a protein called cluster of differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is made up of two parts: a genetically engineered monoclonal antibody that binds to cancer cells with CD25 on their surface, and a toxin produced by bacteria that kills the cancer cells to which it binds. LMB-2 has killed CD 25-containing cells in laboratory experiments and has caused tumors in mice to shrink. Preliminary studies in humans have shown some effectiveness in shrinking tumors in patients with various types of lymph and blood cancers. Patients 18 years of age and older with CLL who have CD25 receptor proteins on their cancer cells and whose disease has progressed within 2 years of treatment with fludarabine may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), echocardiogram, chest x-ray, computed tomography (CT) scans of the chest, abdomen and pelvis, and a bone marrow biopsy. Participants receive up to six cycles of LMB-2 therapy. Each 28-day cycle consists of 30-minute infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an intravenous (IV) catheter (plastic tube placed in a vein) or a central venous line-an IV tube placed in a large vein in the neck or chest that leads to the heart. Patients are admitted to the National Institutes of Health (NIH) Clinical Center for the first treatment cycle. If the infusion is well tolerated, subsequent cycles may be given on an outpatient basis. In addition to drug therapy, patients undergo the following procedures: * Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure blood levels of the drug, evaluate its effects on the cancer cells, and monitor side effects. Blood tests are also done before and duri
Interventions
- DRUG LMB-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2004-02-29 |
| Est. Completion | 2011-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00077922
The ClinicalTrials.gov registry entry for NCT00077922 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LMB-2 is the first listed.
NCT00077922 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00077922 about?
NCT00077922 is a clinical study titled "Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia". This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating chronic lymphocytic leukemia (CLL) in patients who have a protein called cluster of differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is made up of two parts: a genetica...
What is the current status of trial NCT00077922?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2004-02-29. Estimated completion is 2011-12-31.
What interventions are being tested in trial NCT00077922?
The interventions under investigation include: LMB-2 (DRUG).
Who is sponsoring clinical trial NCT00077922?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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