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NCT01341496 · ClinicalTrials.gov registry record · Phase 1
Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT01341496: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01341496 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01341496, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
Background: \- A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a patient and then used to develop a vaccine. The vaccine will produce an immune system response to help destroy other cancer cells in the body. Researchers are studying ways to improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been used safely in other clinical studies. But it has not been studied with certain tumor cell vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given along with cancer drug treatment, is a safe and effective way to slow or prevent tumor growth after tumor removal surgery. Objectives: \- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and drug therapy after tumor removal surgery. Eligibility: \- People at least 18 years of age who have had tumor cell vaccines developed from cells taken from surgically removed tumors. Design: * Patients will be screened with a physical examination, medical history, blood and urine tests, and imaging studies. * Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily) for 7 days before the first vaccine dose. * Patients will receive the tumor cell vaccine once a month for 6 months. They will continue to receive drug therapy throughout the vaccine treatment. Patients will be monitored with regular blood tests and imaging studies. * After the first 6 months, patients who have an immune response to the vaccine will continue treatment with the vaccine and chemotherapy. They will also have regular blood tests and imaging studies. They will have this treatment for up to 24 months from the first vaccination or until they no longer have an immune response. * Participants will have followup visits for up to 5 years after the first vaccination, or until the tumor returns.
Interventions
- DRUG Cyclophosphamide
- DRUG Celecoxib
- BIOLOGICAL Epigenetically Modified Autologous Tumor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2011-04-18 |
| Est. Completion | 2016-07-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01341496
The ClinicalTrials.gov registry entry for NCT01341496 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 41 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 3 interventions - of which Cyclophosphamide is the first listed.
NCT01341496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01341496 about?
NCT01341496 is a clinical study titled "Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal". Background: \- A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a patient and then used to develop a vaccine. The vaccine will produce an immune system response to help destroy other cancer cells in the body. Researchers are studying ways to improve these tu...
What is the current status of trial NCT01341496?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2011-04-18. Estimated completion is 2016-07-21.
What interventions are being tested in trial NCT01341496?
The interventions under investigation include: Cyclophosphamide (DRUG), Celecoxib (DRUG), Epigenetically Modified Autologous Tumor (BIOLOGICAL).
Who is sponsoring clinical trial NCT01341496?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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