lung cencer(lung neoplasms)
Conditions
Interventions
Combination therapy of OK-432 will be administered locally to the tumor site after lung RFA. After the procedure, the tumor size of ablated and not-ablated tumor will be measured and evaluated.
Sponsors
Osaka City University, Department of Diagnostic and Interventional Radiology, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions 1) Patient must not be a candidate for surgical procedure and must be a candidate for the lung RFA 2) Patients must have adequate lung function (PaO2 more than 7mmHg(in room air)) 3) Patients must not have interstitial pneumonia (by imaging and serum KL-6 should be less than 500U/ml) 4) Patients must be more than 20 years old and less than 85 years old 5) Patient's body weight must be less than 100kg 6) Patients must be coherent 7) Patients must be at a score level 0 or 1 of performance status(PS) (ECOG) 8) Patients must be expected to survive more than 2 months 9) Written informed consent must be obtained from patients 10) Patients must not have bleeding tendency 11) Patients have lung tumor which is more than 5 mm on CAT scan and can be ablated by RFA 12) Patients must satisfy the followings: WBC is more than 3,000/mm3 Platelet is more than 50,000/mm3 Serum Creatinine is less than 3.0mg/dl
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1)Patients with bleeding tendency 2)Patients who cannot take a CAT scan 3)Patients with the past history of severe allergic reactions for OK-432 4)Patients with the past history of severe allergic reactions for Penicillin 5)Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety of combination therapy (lung RFA + OK-432). In the Phase I study, optimal dose of OK-432 (0.5,1,2 or 5KE)will be determined by using 3+3 dose escalation method within 1 month. In phase II study, the safety will be confirmed in the optimal dose determined by Phase I study in larger number of patients. Safety will be evaluated by CTCAE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of tumor response of combination therapy (lung RFA + OK-432) in treated tumor and not treated tumor.Evaluation will be performed by CT 1 month after treatment. If positive, measurable lesion is identified in the PET before procedure, PET will be evaluate 1 month after treatment. | — |
Countries
Japan
Contacts
Public ContactAkira Yamamoto
Osaka City University Department of Radiology
Outcome results
None listed