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NCT00670748 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT00670748: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00670748 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00670748, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
Background: -This study uses an experimental cancer treatment that uses the patient s own lymphocytes (type of white blood cell), which are specially selected and genetically modified to target and destroy their tumor. Objectives: -To test the safety of the treatment and determine if it can cause the patient s tumor to shrink. Eligibility: * Patients greater than 18 years and less than or equal to 66 years of age whose cancer has spread beyond the original site and does not respond to standard treatment. * Patients have tissue type human leukocyte antigen (HLA)-A\*0201. * Patients cancer cells have the ESO-1 gene. Design: * Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed. * Patients have leukapheresis to collect cells for laboratory treatment and later reinfusion. For this procedure, whole blood is collected thorough a tube in a vein, the desired cells are extracted from the blood, and the rest of the blood is returned to the patient. * Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune system to receive the treated lymphocytes. * Cell infusion and aldesleukin (IL-2) treatment: Patients receive the lymphocytes by a 30-minute infusion through a vein. Starting within 24 hours of the infusion, they receive high-dose aldesleukin infusions every 8 hours for up to 5 days (maximum15 doses). * Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and aldesleukin. * Tumor biopsy: Patients may be asked to undergo a biopsy (surgical removal of a small piece of tumor) after treatment to look at the effects of treatment on the immune cells in the tumor. * Follow-up: After treatment is completed, patients return to the clinic once a month for several months for physical examinations, a review of side effects, laboratory tests and scans. They may undergo leukapheresis at some visits to look at the effect of treatment on the immune system and check the viability of the infused cel
Interventions
- DRUG Cyclophosphamide
- DRUG aldesleukin
- DRUG fludarabine phosphate
- BIOLOGICAL Anti-NY ESO-1 T-cell receptor PBL
- BIOLOGICAL ALVAC NY ESO-1 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2008-05-29 |
| Est. Completion | 2016-06-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00670748
The ClinicalTrials.gov registry entry for NCT00670748 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 45 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.
NCT00670748 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00670748 about?
NCT00670748 is a clinical study titled "Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer". Background: -This study uses an experimental cancer treatment that uses the patient s own lymphocytes (type of white blood cell), which are specially selected and genetically modified to target and destroy their tumor. Objectives: -To test the safety of the treatment and determine if it can cause...
What is the current status of trial NCT00670748?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2008-05-29. Estimated completion is 2016-06-29.
What interventions are being tested in trial NCT00670748?
The interventions under investigation include: Cyclophosphamide (DRUG), aldesleukin (DRUG), fludarabine phosphate (DRUG), Anti-NY ESO-1 T-cell receptor PBL (BIOLOGICAL), ALVAC NY ESO-1 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00670748?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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