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NCT00314106 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT00314106: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00314106 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00314106, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: * In a study in humans with melanoma, patients given total body irradiation to suppress the immune system in conjunction with chemotherapy showed a significant clinical response. * In previous studies, about one-half of patients given tumor-fighting cells (cells created from the patient's tumor cells and grown in the laboratory) showed some anti-tumor response. Objective: To determine whether tumor-fighting cells taken from a melanoma tumor and grown in the lab can more effectively at fight melanoma when the patient's immune system is suppressed and cannot attack them. Eligibility: Patients 18 years of age or older with metastatic melanoma who have tumor reactive cells available. Design: -Patients are assigned to one of two groups - those having received prior therapy with Interleukin-2 (IL-2) and those who have not. After five days of injections of filgrastim, a medicine to stimulated the growth of white blood cells, patients undergo apheresis or bone marrow harvesting, or both, to collect stem cells for later re-infusion. For apheresis, whole blood is collected through a needle in an arm vein and circulated through a cell-separating machine where the stem cells are extracted. The rest of the blood is returned through the same needle or a needle in the other arm. Bone marrow harvesting is done under general anesthesia. Stem cells are collected through a large needle inserted into the hipbone.-Patients' immune system cells and bone marrow function are eliminated with chemotherapy (7 days) and total body irradiation (3 days) so the patient's immune system cells will not fight the tumor-fighting cells they are given in treatment. * 1 to 3 days after total body irradiation, patients receive the tumor-fighting cells by intravenous (IV) infusion. After the cells are infused, they receive interleukin-2 (IL-2) infusions every 8 hours for 5 days. * 2 days after infusion of the tumor-fighting cells, patients receive the stem cells collected earlier by aphe
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL IL-2
- BIOLOGICAL Melanoma Reactive TIL
- RADIATION 1200 total body irradiation (TBI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-04 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00314106
The ClinicalTrials.gov registry entry for NCT00314106 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 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 5 interventions - of which Cyclophosphamide is the first listed.
NCT00314106 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00314106 about?
NCT00314106 is a clinical study titled "Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma". Background: * In a study in humans with melanoma, patients given total body irradiation to suppress the immune system in conjunction with chemotherapy showed a significant clinical response. * In previous studies, about one-half of patients given tumor-fighting cells (cells created from the patient...
What is the current status of trial NCT00314106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2006-04. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00314106?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), IL-2 (BIOLOGICAL), Melanoma Reactive TIL (BIOLOGICAL), 1200 total body irradiation (TBI) (RADIATION).
Who is sponsoring clinical trial NCT00314106?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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