Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma (NCT01659151) | Clinical Trial Compass
CompletedPhase 2
Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma
United States17 participantsStarted 2012-08-03
Plain-language summary
The purpose of this study is to find out more about the effects of an investigational combination of medicines, which includes special immune cells (T-cells).
A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood cell that protect the body from viral infections, help other cells fight bacterial and fungal infections, produce antibodies, fight cancers, and coordinate the activities of other cells in the immune system.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must have unresectable metastatic stage IV melanoma or stage III intransit or regional nodal disease and in the opinion of the PI or treating Coinvestigator is an acceptable candidate for adoptive cell transfer (ACT).
* Residual measurable disease after resection of target lesion(s) for TIL growth
* Tumor must have a B-RAF V600E, D or K mutation by pyrosequencing, Cobas assay, or equivalent (43)
* Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 - 1. ECOG performance status of 0-1 will be inferred if the patient's level of energy is ≥ 50% of baseline.
* May be treatment-naïve or may have been previously treated for metastatic disease.
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of starting Vemurafenib.
* Adequate renal, hepatic and hematologic function, including creatinine of less than or equal to 1.7 gm/dL, total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dL, aspartic transaminase (AST) and alanine transaminase (ALT) of less than 3X institutional upper limit of normal, hemoglobin of 8 gm/dL or more, white blood count (WBC) of 3000 per mcL and total granulocytes of 1000 per mcL or more, and platelets of 100,000 per mcL or more.
* Must have a positive screening Epstein-Barr Virus (EBV) antibody titre on screening test
* Patients with antibiotic allergies per se are not excluded; altho…
What they're measuring
1
Percentage of Participants With Overall Response (OR)
Timeframe: 12 Months
2
Percentage of Participant Drop Out Rate
Timeframe: Up to 12 months
Trial details
NCT IDNCT01659151
SponsorH. Lee Moffitt Cancer Center and Research Institute