A Study to Assess the Safety and Tolerability of ADI-PEG 20 Combined with Pemetrexed and Cisplatinin in Subjects with Tumors Requiring Arginine

Overview

About this study

The purpose of this study is to assess the safety and tolerability of ADI-PEG 20 combined with pemetrexed and cisplatin in patients with tumors requiring arginine such as advanced malignant pleural mesothelioma, advanced peritoneal mesothelioma (for dose escalation cohort only), non squamous non-small cell lung cancer (stage IIIB/IV), metastatic uveal melanoma, advanced liver cell cancer or recurrent high-grade glioma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Histologically proven advanced malignant pleural mesothelioma, advanced peritoneal mesothelioma (for dose escalation cohort only), non-squamous non-small cell lung cancer (NSCLC) (stage IIIB/IV) or metastatic uveal melanoma or advanced  liver cell cancer or recurrent high-grade glioma
  • Subjects with mesothelioma or NSCLC or uveal melanoma must be chemotherapy naïve except for those EGFR mutant or ALK positive must have had an EGFR tyrosine kinase inhibitor or ALK inhibitor (if available)
  • Subjects with HCC must have already failed sorafenib (due to progressive disease and/or side effects)
  • Subjects with glioma must have already failed radiotherapy ± temozolomide (due to progressive disease and/or side effects)
  • ASS1 deficiency using immunohistochemistry demonstrated on tissue specimen (cytospin specimen are acceptable)
  •  ECOG PS 0-1
  • Expected survival of at least 3 months 
  • Age 18 years or over (there is no upper age limit) 
  • Evaluable disease by modified RECIST criteria for MPM and RECIST 1.1 criteria for peritoneal mesothelioma, non-squamous NSCLC, uveal melanoma, HCC and glioma 
  • Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up 
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria

  • Radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment
  • Ongoing toxic manifestations of previous treatments
  • Symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, NSCLC, uveal melanoma (excludes subjects with HCC or glioma)
  • Major thoracic or abdominal surgery from which the patient has not yet recovered
  • Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Mansfield, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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