Breast Cancer, Colorectal Cancer, Gastric Cancer, Kidney Cancer, Lung Cancer, Melanoma, Ovarian Cancer
Conditions
Brief summary
This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. This protocol is expected to prolong survival of metastatic cancer patients.
Interventions
BIOLOGICALAutologous or Allogeneic tumor cells
Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.
Sponsors
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One of the following metastatic cancers: Melanoma, breast, ovary, colorectal, gastric, lung or kidney * Above 18 years of age * Failure of at least one chemotherapy protocol * Clinical performance status of ECOG 0,1 * Absolute neutrophil count greater than 1000/mm3 * Serum ALT/AST less than three times the upper limit of normal * Serum creatinine less than or equal to 1.6 mg/dl. * Must be able to understand and sign the Informed Consent document
Exclusion criteria
* Below 18 years of age * Women who are pregnant * Life expectancy of less than three months
Countries
Israel
Contacts
Primary ContactHani Steinberg, R.N. B.A.
Backup ContactTamar Peretz, MD
Outcome results
None listed