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NCT01143545 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01143545: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01143545 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143545, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: \- Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific antigens (protein molecules) on their surfaces. Research studies have shown that giving a vaccine that contains antigens similar to these may cause an immune response, which may keep tumors from growing. Researchers are also interested in determining whether the chemotherapy drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work better, particularly in patients with lung cancer. Objectives: \- To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest. Eligibility: \- Individuals at least 18 years of age who have had surgery for small cell or non-small cell lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural mesothelioma. Design: * Following recovery from surgery, chemotherapy, or radiation, participants will have leukapheresis to collect lymphocytes (white blood cells) for testing. * Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7 days before the vaccine. * Participants will have the vaccine in the clinical center (one or two shots per month for 6 months), and will stay in the clinic for about 4 hours after the vaccine. Participants will keep a diary at home of any side effects from the vaccine, and will continue to take cyclophosphamide and celecoxib. * One month after the sixth vaccine, participants will provide another blood sample for testing, and if the tests are satisfactory will return to the clinic every 3 months for 2 additional vaccines. * Participants will return to clinic for follow-up physical examinations, lab tests, and scans every 3 months for 2 years and then every 6 months for up to 3 years.
Primary Outcome
If 25 patients are enrolled and the true probability of a grade 3 or worse toxicity (of any sort) were 20%, then the probability of having 4 or more patients with this occurring is 76.6%. On the other hand, if the combination was very safe and the true probability of a grade 3 or worse toxicity was 5%, then the probability of having 4 or more patients with this occurring would be 3.4%. Thus, if 25 patients were treated, the combination may be considered to have potentially lower safety than tole
Interventions
- DRUG Celecoxib
- DRUG cyclophosphamide
- BIOLOGICAL Allogeneic Tumor Cell Vaccine (K562)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-12-07 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 1 |
Why NCT01143545 stopped before completion
NCT01143545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Celecoxib is the first listed.
NCT01143545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01143545 about?
NCT01143545 is a clinical study titled "Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas". Background: \- Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific antigens (protein molecules) on their surfaces. Research studies have shown that giving a vaccine that contains antigens similar to these may cause an immune response, which may keep tumors from grow...
What is the current status of trial NCT01143545?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-12-07. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT01143545?
The interventions under investigation include: Celecoxib (DRUG), cyclophosphamide (DRUG), Allogeneic Tumor Cell Vaccine (K562) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01143545?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01143545's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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