RecruitingPhase 1ACTRN12609000260224

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).

In patients with malignant mesothelioma (MM) and non-small cell lung cancer (NSCLC) does low-dose iterative cyclophosphamide in combination with conventionally dosed pemetrexed-based chemotherapy decrease regulatory T cell numbers and increase antigen-specific and non-specific cellular immunity.


Sponsor

Sir Charles Gairdner Hospital

Enrollment

33 participants

Start Date

Mar 1, 2009

Study Type

Interventional

Conditions

Summary

This study looks at the effectiveness of the chemotherapy drug cyclophosphamide in combination with pemetrexed-based chemotherapy in people with advanced malignant mesothelioma or advanced non-small cell lung cancer receiving first or second line palliative treatment. Participants will all receive low-dose repeat treatment with cyclophosphamide in combination with the conventional dose of pemetrexed-based chemotherapy commencing from the second cycle of chemotherapy, up to a maximum of 6 cycles. Patients will be monitored for safety at the beginning of treatment, weekly whilst on treatment, and at 90-days follow-up. The tumour will be assessed on CT scan at baseline, after every 2 cycles of treatment, and at least 3 monthly after the completion of treatment, until any progression of the disease. The study aims to see whether this treatment is effective by improving the way the immune system reacts against the cancer by assessing the number/activation/proliferation of various immune cells from weekly blood tests taken at baseline, weekly whilst on chemotherapy, and at 90-day follow-up visit.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a low dose of the drug cyclophosphamide to standard chemotherapy can help the immune system fight cancer better. It is for people with advanced lung cancer (non-small cell type) or a cancer of the lining around the lungs called malignant mesothelioma. The idea is that cyclophosphamide may remove certain immune cells that are blocking the body's natural defences against the cancer. You may be eligible if: - You are 18 years or older - You have been diagnosed with advanced non-small cell lung cancer or malignant mesothelioma - Your cancer is being treated with a chemotherapy regimen that includes pemetrexed - You are in generally good physical condition (ECOG performance status 0 or 1) - You are receiving treatment with the aim of managing (not curing) the disease You may NOT be eligible if: - You have a history of severe autoimmune disease - You are pregnant or breastfeeding - You have had radiation to all areas of measurable cancer - You have a separate cancer diagnosis (with some exceptions for past, successfully treated cancers) - You need to take oral steroids regularly during treatment - You are currently in another clinical trial or receiving immunotherapy Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Cyclophosphamide taken orally once daily (dose ranges from 50mg to 150mg and is titrated according to toxicities and nadir blood T-reg % from last cycle chemotherapy) for the first 14 days of each of

Cyclophosphamide taken orally once daily (dose ranges from 50mg to 150mg and is titrated according to toxicities and nadir blood T-reg % from last cycle chemotherapy) for the first 14 days of each of cycles 2-6. Each cycle is scheduled to last 21 days. Pemetrexed-based chemotherapy regimens include as follows: Pemetrexed single agent 500mg/m2 given IV day 1 of each 21 day cycle. OR Cisplatin 75 mg/m2 given IV and pemetrexed 500 mg/m2 given IV day 1 of each 21 day cycle. OR Carboplatin AUC 4-6 given IV and pemetrexed 500 mg/m2 given IV day 1 of each 21 day cycle. Patients will receive treatment for a maximum of 6 cycles. All pemetrexed-containing regimens will be accompanied by vitamin B12 injection 1000IU 9 weekly and folic acid 0.5 mg daily for the duration of chemotherapy and for at least one month following cessation of chemotherapy as per standard practice.


Locations(1)

WA, Australia

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