Potentiating clinical and immunological effects of chemotherapy by neutralizing acidic pH at tumor site: a phase II randomized study in melanoma patients - ECT-LANS-IL2

ISTITUTO NAZIONALE PER LA CURA TUMORI0 sitesSeptember 3, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 3, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ISTITUTO NAZIONALE PER LA CURA TUMORI

•Patients with metastatic melanoma IIIC / IV M1a meeting the following inclusion criteria will be eligible for the study.
•1\. Age\> 18
•2\. Melanoma skin histo\-and / or cytologically confirmed.
•3\. Non\- Ocular melanoma in advanced stage IIIC / IV M1 with the presence of multiple measurable cutaneous and/or subcutaneous lesions, suitable for biopsy, and for the application of electrodes;
•4\. Number of lesions equal to or greater than six with a minimum size of the lesions of 0\.5 cm.
•5\. Performance status 0\-2 (ECOG).
•6\. Life expectancy ? 3 months.
•7\. Locations of measurable and / or assessed metastases according to RECIST criteria confirmed by imaging. However, the evaluation of the lesions may be carried out using the clinical examination with digital photography and / or by ultrasound.
•8\. A previous chemo\-and/or immune/bio\-chemotherapy and/or vaccination are allowed (however, a washout period of at least 4 weeks is required).
•9\. Normal blood count (neutrophils \> 1500/µL and platelet count\> 130,000/mL), liver function (ALT, AST and alkaline phosphatase \=2\.5 x upper of normal limits \[UNL], and total bilirubin \<3\.0 mg/ml in addition renal function (blood urea nitrogen and creatinine within the normal range, and, in particular, serum creatinine \= 1\.5 x UNL).

•1\.Previous cancers diagnosed within the last 2 years, with the exception of treated basal cell carcinomas or carcinomas in situ of the cervix treated properly.
•2\.Recent major surgery (within 28 days before the start of study treatment).
•3\.Previous treatment with bleomycin at maximum dosage, and different cancer therapies administered within 4 weeks prior to ECT.
•4\.Pregnancy and lactation. Post\-menopausal women should be with amenorrhea for at least 12 months.
•5\.Serious diseases of the liver or lung.
•6\.Short life expectancy (\<3 months) in relation to the evolutionary picture of the disease.
•7\.Evidence of bleeding diathesis or coagulopathy.
•8\.Uncontrolled hypertension;
•9\.Congestive heart failure (NYHA grade ? 2\), previous myocardial infarction or cerebrovascular events within 6 months, pulmonary hypertension, unstable angina, cardiac arrhythmia not adequately controlled by medical treatment which cause decisive alteration in severe cardiac hemodynamics requiring specific treatment;
•10\.Presence of epilepsy or history of significant neurological or psychiatric illness that would compromise the understanding and giving informed consent;