The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma
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