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Trial Title:
Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors
NCT ID:
NCT00722228
Condition:
Colorectal Cancer
Ovarian Cancer
Gastric Cancer
Breast Cancer
Lung Cancer
Kidney Cancer
Melanoma
Conditions: Official terms:
Kidney Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Autologous or Allogeneic tumor cells
Description:
Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of
irradiated and DNP-conjugated tumor cells.
Arm group label:
Autologous or Allogeneic tumor cells
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hadassah Medical Organization
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Tamar Peretz, MD
Email:
Principal Investigator
Start date:
July 2008
Completion date:
January 2022
Lead sponsor:
Agency:
Hadassah Medical Organization
Agency class:
Other
Source:
Hadassah Medical Organization
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00722228
