Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01362790 · ClinicalTrials.gov registry record · Phase 1
SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01362790: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01362790 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362790, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
Background: * Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body's internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for malignant mesothelioma, so researchers are searching for new ways to treat it. * Mesothelin is a protein that is found in mesothelioma and other types of cancer cells. An experimental cancer drug called SS1P is designed to attack cells that have mesothelin while leaving healthy cells alone. Researchers want to test how effective SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune system and may make the SS1P more effective. Objectives: \- To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat malignant mesothelioma. Eligibility: \- Individuals at least 18 years of age who have malignant mesothelioma in the chest or abdomen. Design: * Participants will be screened with a physical exam, medical history, and blood tests. They will also have imaging studies. * The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will follow. * In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14. * On the next three cycles, participants will have pentostatin on day 1.They will have cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6. * Participants will have frequent blood tests and other studies. They will receive all four cycles of treatment as long as there are no severe side effects. * Participants will have regular followup visits as directed by the study doctors.
Interventions
- DRUG Cyclophosphamide
- DRUG Pentostatin
- BIOLOGICAL SS1(dsFv)PE38 - lot 073I0809
- BIOLOGICAL SS1(dsFv)PE38 - lot FIL129J01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-05-11 |
| Est. Completion | 2017-08-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01362790
The ClinicalTrials.gov registry entry for NCT01362790 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 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 4 interventions - of which Cyclophosphamide is the first listed.
NCT01362790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01362790 about?
NCT01362790 is a clinical study titled "SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma". Background: * Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body's internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for malignant mesothelioma, so researchers are ...
What is the current status of trial NCT01362790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2011-05-11. Estimated completion is 2017-08-07.
What interventions are being tested in trial NCT01362790?
The interventions under investigation include: Cyclophosphamide (DRUG), Pentostatin (DRUG), SS1(dsFv)PE38 - lot 073I0809 (BIOLOGICAL), SS1(dsFv)PE38 - lot FIL129J01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01362790?
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.