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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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. 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.
Primary Outcome
Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage
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 |
What the finished NCT01362790 record still lists
NCT01362790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01362790 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01362790's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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