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NCT01336985 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Treating Liver Cancer With Drug-Eluting Beads
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01336985 is a Phase 1 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 5 participants.
The verdict
NCT01336985, a Phase 1 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: * Cancers in other parts of the body often spread to the liver, developing tumors which in many instances cannot be removed with surgery. Liver chemoembolization is a treatment that is routinely performed to control liver tumors in those who cannot have surgery. It has been shown to prolong survival, but does not cure the cancer. During chemoembolization very tiny beads (drug-eluting beads, or DEB) containing chemotherapy drugs (usually doxorubicin) are administered directly into the blood vessels of a liver tumor. The drug within the beads is then released into the tumor whilethe beads temporarily interrupt the tumor s blood supply. * Irinotecan, a drug commonly given intravenously to treat colon cancer, has been given in chemoembolization procedures in four other studies that have shown that the treatment is generally well tolerated. Researchers are interested in determining whether giving the drug irinotecan directly into the liver using drug-eluting beads is not only well tolerated but also provides a larger dose directly to the tumor as determined by tumor and normal liver tissue biopsies. The liver biopsies are an optional portion of the study. Objectives: \- To evaluate the safety and effectiveness of chemoembolization with irinotecan for tumors caused by cancer that has spread to the liver. Eligibility: \- Individuals at least 18 years of age who have melanoma, colon, or another intra-abdominal cancer that has spread to the liver. Design: * Participants will be screened with a physical examination, medical history, blood tests, tumor imaging studies, and liver biopsies. * Participants will receive up to 3 DEB chemoembolization treatments about 6 weeks apart. * After two treatments, participants will have imaging studies to see if the tumors have shrunk, and those whose tumors have shrunk may have a third treatment. * Multiple liver biopsies may be performed and blood samples will be taken to determine how much drug is in the tumor and the
Interventions
- PROCEDURE Biopsy
- DRUG Irinotecan
- PROCEDURE Chemoembolization
- DEVICE Drug-Eluting Beads
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-03-28 |
| Est. Completion | 2011-03-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01336985
The ClinicalTrials.gov registry entry for NCT01336985 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Biopsy is the first listed.
NCT01336985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01336985 about?
NCT01336985 is a clinical study titled "Safety and Pharmacokinetics of Treating Liver Cancer With Drug-Eluting Beads". Background: * Cancers in other parts of the body often spread to the liver, developing tumors which in many instances cannot be removed with surgery. Liver chemoembolization is a treatment that is routinely performed to control liver tumors in those who cannot have surgery. It has been shown to pro...
What is the current status of trial NCT01336985?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2011-03-28. Estimated completion is 2011-03-28.
What interventions are being tested in trial NCT01336985?
The interventions under investigation include: Biopsy (PROCEDURE), Irinotecan (DRUG), Chemoembolization (PROCEDURE), Drug-Eluting Beads (DEVICE).
Who is sponsoring clinical trial NCT01336985?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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