None listed
Conditions
Brief summary
This is a study to determine the maximum dose of CP-870,893 that can be safely administered in combination with standard chemotherapy (cisplatin and pemetrexed) as the treatment of patients with malignant pleural mesothelioma that can't be removed surgically. Who is it for? You can join this study if you have malignant pleural mesothelioma that cannot be removed surgically and are planned to receive treatment with standard chemotherapy (cisplatin and pemetrexed) . Trial details: Participants will receive standard treatment with cisplatin and pemetrexed chemotherapy which is given intravenously every 3 weeks, with the addition of CP-870,893 (CD40 activating antibody) on day 8 of each cycle. CP-870,893 activates the immune system which might help treat the cancer. Assessment for side effects by patient questionnaires and assessment by health professional, and collection of blood tests will occur weekly whilst on treatment and at 90-day follow-up visit. Tumour response will be measured with scans after the first cycle of treatment (PET scan), and after every 2 cycles of treatment (CT scan). The study aims to determine the maximum dose, side effects and effectiveness of CP-870,893 that can be safely administered in combination with standard chemotherapy as the first line treatment for malignant mesothelioma. It will also help to characterise the body's immune response to the treatment. After the maximum dose of CP-870,893 has been determined, 6 patients receiving the treatment at the maximum dose will have biopsies taken of the cancer before treatment starts and at the completion of treatment.
Interventions
addition of CP-870,893 (CD40 activating antibody) to first line treatment with cisplatin (75mg/m2 intravenous injection) and pemetrexed (500mg/m2 intravenous injection) chemotherapy. Chemotherapy to be administered on day 1 of each cycle for a maximum of 6 cycles. CP-870,893 intravenous injection on day 8 of each cycle (starting dose level 0.1mg/kg, dose range for determining tolerability 0.05-2mg/kg) for a maximum of 6 cycles with chemotherapy. Individual participants will receive a specific
addition of CP-870,893 (CD40 activating antibody) to first line treatment with cisplatin (75mg/m2 intravenous injection) and pemetrexed (500mg/m2 intravenous injection) chemotherapy. Chemotherapy to be administered on day 1 of each cycle for a maximum of 6 cycles. CP-870,893 intravenous injection on day 8 of each cycle (starting dose level 0.1mg/kg, dose range for determining tolerability 0.05-2mg/kg) for a maximum of 6 cycles with chemotherapy. Individual participants will receive a specific and fixed dose of CP-870,893. Each cycle is 3 weeks in duration and there will be no planned breaks between cycles. Radiological responders will have the option of continuing treatment with CP-870,893 alone intravenously every 3 weeks for a maximum of a further 6 cycles.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- histologically or cytologically confirmed malignant pleural mesothelioma - planned for first-line treatment with cisplatin and pemetrexed - measurable or evaluable disease on CT (modified RECIST criteria) - Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0-1 - platelets >100, neutrophils >2 - est. calculated creatinine clearance (CrCl) >/= 60ml/min - not pregnant or breast feeding
Exclusion criteria
- unwilling to comply with therapeutic protocol - bilirubin > upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) > 2x ULN, alkaline phosphatase (ALP) > 2.5x ULN - history of severe autoimmune disease - prior radiotherapy to all areas of measurable disease - prior history of thromboembolic disorder - previous or concurrent malignancy (except curatively treated basal cell carcinoma (BCC) of skin, carcinoma-in-situ (CIS) of cervix) unless treated with curative intent >5 years before enrolment - concomitant requirement for oral corticosteroids for >5 days of each treatment cycle - symptomatic central nervous system (CNS) involvement
Outcome results
None listed