Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Beth Israel Deaconess Medical Center
With
Genzyme, a Sanofi Company
To assess the toxicity associated with vaccination of melanoma patients with dendritic cell (DC)/tumor fusions. To determine if cellular and humoral immunity can be induced by serial vaccination with DC/tumor fusions cells. To determine if vaccination DC/tumor fusions results in a tumor response.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment
Patients must be at least 18 years old
Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy
Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.
Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
You may not be if
Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry
Patients must not have received chemotherapy for three weeks prior to the first vaccination
Patients must be without evidence of active CNS disease
Patients must not have clinically significant autoimmune disease
Patients must be HIV negative
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Patients requiring corticosteroids for either melanoma related or co-morbid illness
Clareo Health | The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma
