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Allogeneic Whole Cell Cancer Vaccine for Metastatic Epithelial Tumors
Conditions
Colorectal Cancer - Ovarian Cancer - Gastric Cancer - Breast Cancer - Lung Cancer
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
N/A
Intervention
Name: Allogeneic whole epithelial tumor cells, DNP-conjugated and irradiated
Type: Biological
Overall Status
Not yet recruiting
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 colorectal, gastric, ovarian, breast or lung 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 epithelial cancer patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Metastatic epithelial cancer
- 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
- Metastatic epithelial cancer
- 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
Location
Hadassah Medical Organization
Jerusalem, Israel
Status: Not yet recruiting
Sponsors
Hadassah Medical Organization
Source
Hadassah Medical Organization
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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