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NCT01271907 · ClinicalTrials.gov registry record · Phase 2
Drosophila-generated CTL
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01271907: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01271907 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01271907, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * Recent cancer treatment studies have shown that altering a cancer patient's own white blood cells may help the immune system fight the cancer. In all of these studies, participants donate their own white blood cells through a procedure called leukapheresis, and the cells are altered in the laboratory and given back to the participants. After the cells are given, the patients receive aldesleukin (IL-2) to help the tumor fighting cells stay alive longer. For individuals with metastatic melanoma, pieces of melanoma proteins may be added to the collected white blood cells to help the immune system recognize and attack the cancer cells. * Researchers are interested in testing a new process in which cells from fruit flies (Drosophila) are used to help the melanoma proteins attach to the white blood cells. The fruit fly cells die off shortly after the proteins are introduced to the white blood cells. Researchers are also interested in determining whether IL-2 treatment is necessary after this new cancer treatment process. Objectives: * To test the safety and effectiveness of modified white blood cells (Drosophila-generated CTL) as a treatment for metastatic melanoma that has not responded to standard treatments. * To determine whether IL-2 treatment improves the effectiveness of Drosophila-generated cytolytic T lymphocytes (CTL). Eligibility: \- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma that has not responded to previous IL-2 treatment. Design: * Participants will be screened with a physical examination and medical history, tumor imaging studies, and heart and lung function tests. * Prior to treatment, participants will have an intravenous catheter inserted into the chest to administer the study drugs. * Participants will have leukapheresis to provide white blood cells for laboratory modification. * Seven days before the start of the treatment, participants will be admitted to the hospital to have chemotherap
Interventions
- DRUG Aldesleukin
- DRUG fludarabine
- DRUG cyclophosphamide
- DRUG Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-04-15 |
| Est. Completion | 2011-12-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01271907
The ClinicalTrials.gov registry entry for NCT01271907 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 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 4 interventions - of which Aldesleukin is the first listed.
NCT01271907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01271907 about?
NCT01271907 is a clinical study titled "Drosophila-generated CTL". Background: * Recent cancer treatment studies have shown that altering a cancer patient's own white blood cells may help the immune system fight the cancer. In all of these studies, participants donate their own white blood cells through a procedure called leukapheresis, and the cells are altered i...
What is the current status of trial NCT01271907?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2011-04-15. Estimated completion is 2011-12-08.
What interventions are being tested in trial NCT01271907?
The interventions under investigation include: Aldesleukin (DRUG), fludarabine (DRUG), cyclophosphamide (DRUG), Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (DRUG).
Who is sponsoring clinical trial NCT01271907?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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