Evaluation of chemotherapy followed by multivalent dendritic cell vaccines and Ipilimumab for Stage IV metastatic melanoma.

Andrew Nicol0 sites50 target enrollmentOctober 31, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Andrew Nicol

•1\) Patients with metastatic stage IV metastatic melanoma and measurable disease as defined by the most recently published RECIST criteria.
•2\) Written informed consent
•3\) ECOG performance status 0, 1 or 2
•4\) Subject judged to be able to safely undergo leukapheresis
•5\) Age greater than or equal to 16 years.
•6\) Life expectancy estimated to be greater than 4 months
•7\) Availability of tumour sample or an alternative source of tumour antigen

•1\) Any concurrent therapy with possible activity against the patient’s malignancy (local radiotherapy on lesions not essential for study evaluation is allowed)
•2\) Concurrent therapy with any agent known to have immune modulating activity
•3\) Any therapy with possible activity against the patient’s malignancy in the month preceding administration of first dose of study therapy
•4\) Patient unable to undergo leukapheresis due to serious co\-existing medical conditions (particularly cardiac or cardiovascular) or for other reasons
•5\) ECOG \> 2
•6\) Pregnant or breast feeding or at risk for becoming pregnant within 3 months of enrolment
•7\) HIV, Hepatitis B or Hepatitis C positive
•8\) Patients with history of autoimmune disease affecting the liver, gastrointestinal tract (e.g. ulcerative colitis or Crohn's disease), neurological system (including Guillaine Barre Syndrome and Myasthenia Gravis) and autoimmune pituitary or adrenal disease.
•9\) Active CNS disease requiring steroids