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NCT01369875 · ClinicalTrials.gov registry record · Phase 2
Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01369875: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01369875 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369875, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: \- Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor tissue. The cells are modified to help them kill tumor cells, then given back to the person with cancer. By giving these cells to patients, researchers hope to improve the current treatments available for patients with melanoma that has not responded to standard therapies. The TIL will be given after treatments that will suppress the immune system. This makes it easier for the TIL to attack the cancer cells. The TIL will also be given with aldesleukin (IL-2), which is designed to help keep the TIL cells alive in the body. Objectives: \- To study the safety and effectiveness of specially modified tumor infiltrating lymphocytes to treat melanoma that has not responded to other treatments. Eligibility: \- Individuals at least 18 years of age who have metastatic melanoma that has not responded to other treatments. Design: * Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies. * A piece of tumor will be collected and white blood cells will be separated to make the TIL for the treatment. * Participants will take drugs to suppress the immune system for 7 days before the start of treatment. * Participants will receive the TIL in a single dose. Then they will receive IL-2 every 8 hours for up to 15 doses. Participants will remain in the hospital for up to 2 weeks after treatment. They will be monitored with frequent blood tests and other studies. * After leaving the hospital, participants will have regular followup visits every 1 to 4 months for the first year. Then they will return for followup every 3 to 4 months, as directed by the study researchers.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Tumor Infiltrating Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-06-17 |
| Est. Completion | 2012-02-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369875
The ClinicalTrials.gov registry entry for NCT01369875 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 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 Cyclophosphamide is the first listed.
NCT01369875 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01369875 about?
NCT01369875 is a clinical study titled "Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma". Background: \- Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor tissue. The cells are modified to help them kill tumor cells, then given back to the person with cancer. By giving these cells to patients, researchers hope to improve the current treatments av...
What is the current status of trial NCT01369875?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2011-06-17. Estimated completion is 2012-02-14.
What interventions are being tested in trial NCT01369875?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (BIOLOGICAL), Tumor Infiltrating Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01369875?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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