Status:
TERMINATED
SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Mesothelioma
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief 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 con...
Detailed Description
Background: SS1P (dsFv) PE38, is a recombinant immunotoxin targeting the tumor antigen mesothelin that is highly expressed in malignant mesothelioma. The maximum tolerated dose (MTD) of SS1 dsFv has ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects must meet all of the following criteria to be eligible to participate in the study:
- Subjects must have histologically confirmed epithelial or biphasic pleural mesothelioma not amenable to potentially curative surgical resection. However, patients with biphasic tumors that have a predominantly sarcomatoid component will be excluded.
- Measurable disease
- Subjects must be greater than or equal to 18 years old
- Karnofsky Performance Status (KPS) of greater than or equal to 70
- Life expectancy of greater than 3 months, as assessed by the principal investigator.
- Adequate organ function with:Hepatic function: serum transaminases (either ALT or AST) or bilirubin, less than or equal to Grade 1, unless due to cancer or Gilbert s disease; less than or equal to Grade 2, if due to cancer
- Renal function: serum creatinine clearance greater than or equal to 60mL/min as estimated by Cockroft-Gault formula.
- Bone marrow function: ANC of at least 1,500/mm (3), Platelet count at least 100,000/mm (3)
- Pulmonary Function: FEV (1) greater than or equal to 50 percent of predicted value (post-pleural drainage and bronchodilation if these are indicated)
- Must be able to understand and sign informed consent
- Female and male subjects agree to use an approved method of contraception during the study
- EXCLUSION CRITERIA:
- Subjects must not be pregnant or breast feeding
- Prior radiotherapy (except palliative extra-thoracic localized radiotherapy) or biologic therapy for malignant pleural mesothelioma within 4 weeks
- Prior systemic chemotherapy for malignant pleural mesothelioma
- Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion but the CNS metastases should have been adequately treated (radiation or surgical resection) and subjects are free from symptoms for 3 months off steroids).
- Clinically significant heart disease (New York Heart Association Class III or IV)
- Active bacterial or fungal infection.
- Baseline coagulopathy greater than or equal to Grade 3 unless due to anticoagulant therapy
- Surgery or pleurodesis within 2 weeks
- HIV positive serology (due to increased risk of severe infection and unknown interaction of SS1(dsFv)PE38 with antiretroviral drugs)
- Hepatitis B surface antigen positivity
- Subjects with other (non-mesothelioma) cancers who meet eligibility criteria and have had less than 5 years of disease-free survival will be considered on a case-by-case basis
- Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
Exclusion
Key Trial Info
Start Date :
November 14 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01445392
Start Date
November 14 2007
End Date
October 3 2016
Last Update
August 3 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892