At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage IIIC or stage IV melanoma
- ✓Measurable disease
- ✓Age 18 or older
- ✓ECOG performance status of 0 or 1
- ✕Symptomatic or untreated brain metastasis
- ✕Any serious ongoing infection
- ✕Current corticosteroid or other immunosuppressive therapy
- ✕Any pre-existing immunodeficiency condition (including known HIV infection)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma
In Brief
A Phase 2 clinical trial evaluating Bystander-Based Autologous Tumor Cell Vaccine for Melanoma (Skin). Completed, enrolled 43 participants across 1 site.
Detailed Summary
The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.
Study Details
Timeline
Interventions
The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.