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NCT01313429 · ClinicalTrials.gov registry record · Phase 1
Tumor Cell Vaccine for Patients Undergoing Surgery for Sarcomas, Melanomas, Germ Cell Tumors, or Malignancies That Have Metastasized to the Lungs, Pleura, or Mediastinum
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01313429: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01313429 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313429, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Background: \- Certain types of cancers, including sarcoma and melanoma, have specific antigens (protein molecules) on their surfaces. Research has shown that producing an immune reaction to these antigens may be able to keep tumors from growing by encouraging the immune system to destroy the tumor cells. By creating a vaccine that contains antigens similar to those found on the cancer cells, researchers hope to cause an immune reaction that targets the cancer cells. However, more research is needed to determine the safety and effectiveness of this type of vaccine treatment. Objectives: \- To determine whether a tumor cell vaccine, given to individuals who have had surgery to remove malignant tumors from the chest, can cause an immune reaction that will prevent the tumors from coming back. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with cancer that has spread to the lungs, pleura, or mediastinum, and have recently had surgery to remove tumors in the chest. Design: * Participants will be screened with a physical examination and medical history, as well as blood tests and imaging studies. * Participants will have the option to have leukapheresis to collect white blood cells for studies on how the body is responding to the vaccine. Participants who agree to have this procedure will have it before the start of treatment and after the sixth and eighth vaccines. * Seven days before the first vaccine, participants will receive the chemotherapy drugs celecoxib and cyclophosphamide to take twice a day at home. * Participants will receive the experimental vaccine as an injection in the thigh or arm, and may receive it in two shots depending on how many cells are in each vaccine. Participants will receive a diary to monitor medication doses and side effects, as well as additional cyclophosphamide and celecoxib to take at home as directed by the study. * Participants will have one vaccine every month for 6 months, and will have regular b
Primary Outcome
List of adverse event frequency
Interventions
- DRUG Cyclophosphamide
- DRUG Celecoxib
- BIOLOGICAL Allogenic tumor Cell Vaccine (K562)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-03-04 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 1 |
Why NCT01313429 stopped before completion
NCT01313429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01313429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313429 about?
NCT01313429 is a clinical study titled "Tumor Cell Vaccine for Patients Undergoing Surgery for Sarcomas, Melanomas, Germ Cell Tumors, or Malignancies That Have Metastasized to the Lungs, Pleura, or Mediastinum". Background: \- Certain types of cancers, including sarcoma and melanoma, have specific antigens (protein molecules) on their surfaces. Research has shown that producing an immune reaction to these antigens may be able to keep tumors from growing by encouraging the immune system to destroy the tumor...
What is the current status of trial NCT01313429?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-03-04. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT01313429?
The interventions under investigation include: Cyclophosphamide (DRUG), Celecoxib (DRUG), Allogenic tumor Cell Vaccine (K562) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01313429?
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 NCT01313429's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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