Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin

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Brief Title

Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin

Official Title

Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin

Brief Summary

      Background:

      Cancers that spread into the thin tissue lining your lungs (pleura) cause serious illness.
      They often recur when removed. These tumors include malignant pleural mesothelioma (MPM),
      caused by exposure to asbestos and related fibers. Malignant pleural effusions (MPEs) are
      caused when cancers in other parts of the body spread to the lungs and pleura. Many people
      diagnosed with pleural tumors survive less than a year.

      Objective:

      To test the safety of a study drug (LMB-100) in people. LMB-100 may help stop pleural tumors
      from recurring after surgery.

      Eligibility:

      People aged 18 years or older diagnosed with MPM or related cancer that has spread into the
      pleura.

      Design:

      Participants will undergo screening. They will have a physical exam with blood and urine
      tests. They will have CT scans. They will have tests that measure the how their heart and
      lungs function. They will provide a sample of tumor tissue to determine if their tumor
      expresses a protein called mesothelin.

      Participants will undergo standard surgery to maximally remove the plural tumors. Then they
      will have LMB-100 pumped into their chest. The liquid will rinse the chest wall, diaphragm,
      heart sac, and surface of the lungs for 90 minutes. Then the liquid will be drained and the
      surgical incisions closed. The participants will be under anesthesia during this procedure.

      Participants will remain in the intensive care unit for a least 48 hours. They will remain in
      the hospital for up to a week or more until recovered enough to be safely discharged.

      Participants will return for regular follow-up visits for 2 years.
    

Detailed Description

      Background

        -  Malignant pleural mesotheliomas (MPM) are aggressive cancers with a high predilection
           for intrapleural recurrences despite potentially curative resections.

        -  Pleural metastases and associated malignant pleural effusions (MPE) cause considerable
           morbidity and mortality in patients with lung and esophageal cancers, gastrointestinal,
           pancreatic, and ovarian carcinomas, as well as sarcomas.

        -  Mesothelin (MSLN), a tumor differentiatio antigen, is expressed in over 95% of
           epithelioid MPM, as well as 80% of thymic carcinomas, 50% of lung and gastroesophageal
           cancers, 75% of pancreatic carcinomas, and 30% of ovarian carcinomas and synovial
           sarcomas.

        -  Mesothelin is an attractive target for cancer therapy due to its limited expression in
           normal human tissues and effects on invasion and metastasis of cancer cells.

        -  LMB-100 is a novel recombinant anti-mesothelin immunotoxin containing a humanized
           fragment of an anti-mesothelin Fab conjugated to a de-immunized Pseudomonas exotoxin A
           (PEA) which exhibits broad activity against cancer lines and tumor xenografts expressing
           mesothelin.

        -  Despite de-immunizing modifications, LMB-100 still induces neutralizing antibodies that
           prevent repeated systemic administration of this immunotoxin.

        -  Local (intraperitoneal) administration of LMB-100 can eradicate low-volume
           carcinomatosis in a murine model of minimal residual disease.

        -  Conceivably, intracavitary administration of LMB-100 following cytoreductive surgery may
           enhance local control of pleural-based malignancies that express mesothelin while
           minimizing systemic exposure of the immunotoxin.

      Primary Objective

      -To identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered
      by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive
      MPM, or MPE from cancers that express mesothelin.

      Eligibility

        -  Age >= 18 years

        -  Histologically confirmed mesothelioma, or other mesothelin-positive malignancy
           metastatic to the pleura, potentially amenable to cytoreductive surgery and subsequent
           intrapleural perfusion.

        -  No systemic or local therapy for their malignancy within 3 weeks prior to protocol
           treatment.

        -  Adequate organ function and cardiopulmonary reserve to tolerate intended resection.

        -  No active infections.

        -  No active central nervous system (CNS) metastases.

      Design

        -  Participant s will undergo maximal cytoreductive surgery for their malignancies by open
           or minimally invasive procedures as dictated by histologic, anatomic, and physiologic
           parameters.

        -  Thereafter, LMB-100 will be administered by 90-minute normothermic intrathoracic
           perfusion using a closed circuit and roller pump with a heat exchanger.

        -  LMB-100 levels will be measured in pulmonary lavage and plasma.

        -  The dose of LMB-100 will be increased using a 3 plus 3 design to define MTD.

        -  Once the MTD has been defined, the enrollment will be expanded to more fully define
           toxicities and evaluate time to disease progression and overall survival (OS) using 2
           separate cohorts of participants with MPM and pleural effusions from other malignances
           (MPE).

        -  The accrual ceiling will be set at 42.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin

Secondary Outcome

 Determine 2 year progression free survival (PFS), and 3 year overall survival of participants following intrapleural LMB-100 perfusion

Condition

Malignant Pleural Mesotheliomas (Mpm)

Intervention

Cytoreductive surgery

Study Arms / Comparison Groups

 1/ Dose Escalation
Description:  LMB-100 at escalating/de-escalating doses + MSLN testing

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

42

Start Date

July 6, 2022

Completion Date

December 31, 2027

Primary Completion Date

December 31, 2026

Eligibility Criteria

        -INCLUSION CRITERIA:

          1. Histologically confirmed by the Laboratory of Pathology (LP), CCR, NCI
             mesothelinpositive malignancy metastatic to the pleura that is potentially amenable to
             cytoreductive surgery (R0-R2) and subsequent intrapleural perfusion.

          2. Participants with biphasic MPM must have a < 50% sarcomatoid component.

          3. Participants with MPE from extra-thoracic disease may be eligible provided these sites
             are controlled and are less threatening than the pleural involvement LENT score >=2 .

          4. Participants with stage IV cancers affecting the pleura with MPE must have received
             firstline standard of care systemic treatment for their malignancies.

          5. MPM participants must not have received any local or systemic therapy for their
             disease.

          6. All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure
             must have resolved to Grade <= 1 except hemoglobin (Hgb) <= Grade 2, alopecia (any
             grade), and <= Grade 2 peripheral neuropathy.

          7. Age >18 years.

          8. ECOG performance status of < 2.

          9. Participants must have adequate pulmonary reserve evidenced by post-operative
             predicted FEV1 and adjusted DLCO >= 40% predicted.

         10. Room air oxygen saturation >= 90%; otherwise pCO2 <= 45 and pO2 >= 60 on room air
             arterial blood gas (ABG).

         11. Adequate organ and marrow function as defined below:

               -  leukocytes >=3,000/mcL

               -  absolute neutrophil count >=1,500/mcL (without transfusion or cytokine support)

               -  absolute lymphocyte count > 800/mcL

               -  platelets >=100,000/mcL

               -  Hgb >=9 g/ dL (with transfusion if necessary, within 1 week prior to treatment)

               -  serum albumin >= 2.0 mg/dL

               -  AST/ALT <= 2.5 X institutional ULN

               -  creatinine clearance (eGFR) >=50 mL/min/1.73 m^2 by Cockcroft-Gault formula

               -  INR <= 1.5 x ULN

               -  TSH, T3 and T4 within normal limits (WNL) per institutional criteria

               -  random serum cortisol within normal limits (WNL) per institutional criteria

               -  total bilirubin < 1.5 X institutional ULN (excluding Gilbert s Syndrome)

         12. Participants with a history of brain metastases except those with meningeal
             carcinomatosis or leptomeningeal disease may be eligible for treatment a minimum of 1
             week following completion of gamma knife or whole-brain radiotherapy, or 4 weeks

             following surgical resection of brain metastases provided post-treatment MRI scan
             reveals no evidence of active disease and no ongoing need for systemic steroids.

         13. Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) at the study entry, for the
             duration of study treatment and up to 4 months (women) or 2 months (men) after the
             last dose of the study drug.

         14. Breastfeeding participants must be willing to discontinue breastfeeding from study
             enrollment through two months after the LMB-100 perfusion.

         15. HBV-infected participants must be on antivirals and have HBV DNA <100 IU/mL.
             HCV-infected participants can be enrolled if HCV RNA level is undetectable.

         16. The ability of the participant to understand and the willingness to sign a written
             informed consent.

         17. Participants must be enrolled into protocol 06C0014 "Prospective Evaluation of Genetic
             and Epigenetic Alterations in Patients with Thoracic Malignancies".

         18. Participants must provide acceptable archival tumor samples or have at least 1 focus
             of disease that is amenable to tumor biopsy if necessary for confirmation of
             histology, and assessment of mesothelin expression.

        EXCLUSION CRITERIA:

          1. Active smokers.

          2. Participants receiving systemic steroids other than physiologic replacement doses or
             inhaled corticosteroids (<= 20 mg of dexamethasone a day [or equivalent]) for <= 7
             consecutive days prior to treatment initiation).

          3. Treatment with chemotherapy, targeted therapy, immunotherapy, radiation, or surgery to
             an index lesion within three weeks prior to commencing protocol therapy, excluding
             minor surgical procedures (i.e. VATS/thoracentesis/PleurX catheter placement to
             palliate

             MPE).

          4. Treatment with another investigational agent within four weeks prior to commencing
             protocol therapy.

          5. History of allergic reactions attributed to compounds of chemical or biologic
             composition similar to LMB-100 or SS1P including pseudomonas endotoxin.

          6. Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral
             vascular accident/stroke (within 6 months prior to treatment initiation) or myocardial
             infarction (within 6 months prior to treatment initiation) unless revascularized,
             unstable angina, congestive heart failure (New York Heart Association Classification
             Class >= II), serious cardiac arrhythmia, abnormal ejection fraction (echocardiogram
             [ECHO]) <= 40%, clinically significant bleeding or clinically significant pulmonary
             embolism.

          7. History of pneumonitis (idiopathic or drug-induced) unless cleared by pulmonary
             consultants.

          8. Receipt of any organ transplantation, including allogeneic stem-cell transplantation,
             except transplants that do not require immunosuppression (e.g., corneal transplant,
             hair transplant).

          9. HIV-infected participants. Participants on stable doses of antiretroviral therapy
             whose HIV RNA is below level of quantification are eligible.

         10. Active COVID-19 infection.

         11. Active infections requiring systemic therapy.

         12. An additional malignancy that is progressing or requires active treatment.

         13. Pregnancy

         14. Uncontrolled intercurrent illness or psychiatric illness/social situations that would
             limit compliance with study requirements.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David S Schrump, M.D., (240) 858-3974, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05375825

Organization ID

10000062

Secondary IDs

000062-C

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

David S Schrump, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

May 11, 2022