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NCT00393029 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00393029: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00393029 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00393029, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Background: The p53 gene normally suppresses tumor growth, but when it is mutated, or damaged, tumors can grow unchecked. In cancers where the p53 gene has mutated, an increased level of p53(overexpression of p53) can be measured in the tumor. Objectives To determine whether advanced cancers that overexpress p53 can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-p53 protein. Eligibility Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) Patient's tumor overexpresses p53 Patient's leukocyte antigen type is HLA-A 0201 Design Patients undergo the following procedures: Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-p53 protein is inserted into the cells using an inactivated (harmless)virus in a process called transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) for 1 week to suppress the immune system so that the patients immune cells do not interfere with the treatment. Treatment with anti-p53 cells. Patients receive an IV infusion of the transduced cells containing anti-p53 protein, followed by infusions of a drug called IL-2, which helps boost the effectiveness of the transduced white cells. Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). Patients are evaluated with laboratory tests and imaging tests, such as computed tomography (CT) scans 4 to 6 weeks after treatment and then once a month 3 to 4 months to determine the response to treatment. Patients have blood tests at 1, 3, 6 and 12 months and then annually for the next 10 years.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- BIOLOGICAL aldesleukin
- BIOLOGICAL filgrastim
- BIOLOGICAL anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00393029
The ClinicalTrials.gov registry entry for NCT00393029 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 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.
NCT00393029 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00393029 about?
NCT00393029 is a clinical study titled "Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes". Background: The p53 gene normally suppresses tumor growth, but when it is mutated, or damaged, tumors can grow unchecked. In cancers where the p53 gene has mutated, an increased level of p53(overexpression of p53) can be measured in the tumor. Objectives To determine whether advanced cancers that...
What is the current status of trial NCT00393029?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2006-10. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00393029?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), aldesleukin (BIOLOGICAL), filgrastim (BIOLOGICAL), anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00393029?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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