A Phase I Dose Escalation Trial of Dendritic Cell-Based Vaccination for Stage IV Melanoma Patients.
The purpose of the study is to assess the dose limiting toxicity for dendritic cells pulsed with autologous tumor lysate and matured using a Dendritic Maturation Cocktail composed of IL-1 beta, IL-6, TNF alpha, and PGE2, injected intranodally with KLH in Stage IV melanoma patients.
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Patients may qualify if:
·They are age 18 or older with a diagnosis of melanoma that has metastasized to other parts of the body (but not the brain) [Stage IV].
·There is presence of a melanoma tumor large enough (about 2 x 2 cm.) to be surgically removed for use in making the vaccine, and;
·Additional disease that can be evaluated/measured for response during the course of the trial.
·The patient is able to care for self and well enough to carry out light or sedentary activities.
A specially prepared vaccine will be injected into a lymph node on days one, 15 and 29 of the trial. If the disease has gotten better or not worsened, the patient may receive additional injections based on desire, clinical status and availability of vaccine.
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