SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma
Status:
Terminated
Trial end date:
2016-10-03
Target enrollment:
Participant gender:
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
for women who can become pregnant.
- Questions about medications and side effects.
- Blood and urine tests.
- Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests,
pulse oximetry, performance of daily activities and quality-of-life questionnaires.
Post-treatment evaluations:
- Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease
assessment.
- End-of-study visit for blood tests, vital signs and weight measurements, disease
assessment, electrocardiogram, pregnancy test for women who can become pregnant