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NCT01495572 · ClinicalTrials.gov registry record · Phase 2
Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01495572: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01495572 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495572, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: \- Some cancer treatments collect a patient s own blood cells to use as specialized cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new cells grow. Researchers want to see if special white blood cells that recognize a specific protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART)) can cause tumors to shrink. These white blood cells will be tested with and without aldesleukin. Objectives: * To test the safety and effectiveness of white blood cells that target MART in the treatment of melanoma. * To test white blood cells that target MART with and without aldesleukin. Eligibility: \- Individuals at least 18 years of age who have melanoma that has not responded to standard treatments. Design: * Participants will be screened with a medical history and physical exam. Blood and urine samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging scans will be performed. * Participants will provide white blood cells through leukapheresis. Researchers will attempt to isolate white blood cells that recognize MART * Seven days before the start of treatment, participants will have chemotherapy. * After the last dose of chemotherapy, participants will receive the MART reactive PBL cells. Filgrastim doses will also be given to help white blood cell counts return to normal. Participants will have frequent blood tests. * Participants who are able to have aldesleukin treatment will start within 24 hours after receiving the MART reactive PBL cells. Treatment will continue for up to 5 days. * Participants may have an optional tumor or lymph node biopsy to study the effects of treatment. * If the tumor continues to
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- DRUG MART-1 Reactive CD8+ PBL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01495572
The ClinicalTrials.gov registry entry for NCT01495572 describes a study currently listed as terminated, categorized as Phase 2. 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 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.
NCT01495572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01495572 about?
NCT01495572 is a clinical study titled "Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells". Background: \- Some cancer treatments collect a patient s own blood cells to use as specialized cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with PBL, chemotherapy is given to ...
What is the current status of trial NCT01495572?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2011-12. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01495572?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), MART-1 Reactive CD8+ PBL (DRUG).
Who is sponsoring clinical trial NCT01495572?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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