Metastatic Melanoma
Conditions
Keywords
melanoma
Brief summary
This study aims to determine if the vacccine can be used safely in patients with advanced melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of producing immune responses against your own cancer.
Detailed description
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.
Interventions
BIOLOGICALDC/tumor fusion vaccine
SC vaccinations administered to each patient at 3-week intervals for 2-3 doses
Sponsors
Beth Israel Deaconess Medical Center
Genzyme, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Labs: WBC \>\_ 2.0 x 10x3/uL, Bilirubin \<\_2.0 mg/dL, Creatine \<\_ 2.0mg/dL * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the toxicity, cellular and humoral immunity and tumor response in patient with melanoma receiving the DC/tumor fusion vaccine | screening/baseline, treatment period and follow-up |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Avigan, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed