Optimising regulatory T cell depletion with cyclophosphamide in combination with chemotherapy for enhanced anti-tumour immunity in patients with non-small cell lung cancer (NSCLC) and malignant mesothelioma (MM).

Phase 1

Recruiting

• Conditions: Malignant Mesothelioma; Non small cell lung cancer; Cancer - Lung - Mesothelioma; Cancer - Lung - Non small cell

• Registration Number: ACTRN12609000260224
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) or malignant mesothelioma (MM) planned for treatment with a pemetrexed-containing regimen.
Treatment of advanced disease with palliative intent.
First or second line treatment.
Measureable or evaluable disease as defined by the RECIST criteria (NSCLC) or Modified RECIST (MM).
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclusion Criteria

History of severe autoimmune disease.
Radiotherapy to all areas of measureable disease.
Previous or concurrent malignancy diagnosis (except curatively-treated basal cell carcinoma (BCC) of skin, carcinoma in situ of cervix) unless treated with curative intent more than 5 years before enrolment.
Concomitant requirement for oral corticosteroids for more than 5 days of each treatment cycle.
Concomitant treatment with other investigational agents or immunotherapy.
Pregnant or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the depletion of CD25+ Foxp3+ CD4+ Treg cells during/after pemetrexed-based chemotherapy and cyclophosphamide (expressed as the proportion of Foxp3+ CD25+ CD4+ T cells in the total CD4 T cell pool before and after treatment) as assessed with antibody staining of peripheral blood mononuclear cells for markers of T-cell function/activation/proliferation.[At baseline, weekly whilst receiving chemotherapy, and at 90-day follow-up visit.]