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Investigator(s):
Raffit Hassan, M.D. Principal Investigator Phone: 301-451-8742
Referral Contact(s):
Barbara Schuler, R.N., O.C.N., C.C.R.P. Research Nurse Phone: 301-435-5398 schulerb@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed epithelial pleural mesothelioma not amenable to potentially curative surgical resection
• Unresectable disease, defined as any one of the following:
• Metastatic disease
• Patient found at surgery not to be amenable to resection
• Not to benefit from surgery due to extensive local disease or not a surgical candidate due to comorbid medical conditions as deemed by a qualified oncologist
• Measurable disease
• No documented and ongoing central nervous system involvement (history of CNS involvement is not an exclusion criterion)
• > 4 weeks since prior radiotherapy (except palliative extra-thoracic localized radiotherapy) or biologic therapy for malignant pleural mesothelioma
• > 2 weeks since prior surgery or pleurodesis
• No prior systemic chemotherapy for malignant pleural mesothelioma
• ≥ 18 years old
• Karnofsky 70–100%
• ALT, AST, or bilirubin ≤ grade 1 (unless due to cancer or Gilbert disease) OR ≤ grade 2 (if due to cancer)
• Serum creatinine clearance ≥ 60mL/min
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Not pregnant or nursing; fertile patients must use effective contraception
• FEV₁ ≥ 50 percent of predicted value (post-pleural drainage and bronchodilation if these are indicated)
• Other (non-mesothelioma) cancers that meet eligibility criteria and have had < 5 years of disease-free survival are considered on a case by case basis
• May only be enrolled in this study once (i.e., no second time or later cohort re-enrollment)
• No clinically significant heart disease (New York Heart Association Class III or IV)
• No active bacterial or fungal infection
• Baseline coagulopathy < grade 3 (unless due to anticoagulant therapy)
• HIV and hepatitis B negative
• No uncontrolled, symptomatic, and/or intercurrent illness that would preclude study participation

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Treatment Plan:

This is a dose-escalation study of SS1(dsFv)-PE38 immunotoxin.

• Patients receive SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on Days 1, 3, and 5, pemetrexed disodium IV over 10 minutes on Day 1, and cisplatin IV over 2 hours on Day 1 in courses 1 and 2
• Beginning in course 3 and all subsequent courses, patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on Day 1
• Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
• Patients undergo blood sample collection at baseline, prior to course 2, and day 21 of course 2 for laboratory and pharmacokinetic studies
• Patients are followed every 2-3 months in order to assess disease status

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/13/08
Updated: 11/14/08