Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01445392 · ClinicalTrials.gov registry record · Phase 1
SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01445392: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445392 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445392, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen. SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells. Objectives: To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma. To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects). To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients tumors. To learn how the body breaks down SS1(dsFV)PE38. Eligibility: Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy. Design: Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows: * Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin. * Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38. * Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined. Continuing standard treatment with additional cycles of pemetrexed and cisplatin. Evaluations during the treatment period: * Physical examination, including vital signs and body weight checks, and pregnancy test f
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- BIOLOGICAL Multicycle SS1P
- BIOLOGICAL Single cycle SS1P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-11-14 |
| Est. Completion | 2016-10-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445392
The ClinicalTrials.gov registry entry for NCT01445392 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 24 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 Cisplatin is the first listed.
NCT01445392 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01445392 about?
NCT01445392 is a clinical study titled "SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma". Background: Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen. SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that bind...
What is the current status of trial NCT01445392?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2007-11-14. Estimated completion is 2016-10-03.
What interventions are being tested in trial NCT01445392?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Multicycle SS1P (BIOLOGICAL), Single cycle SS1P (BIOLOGICAL).
Who is sponsoring clinical trial NCT01445392?
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.