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Allogeneic Whole Cell Cancer Vaccine for Metastatic Epithelial Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722228
First Posted: July 25, 2008
Last Update Posted: July 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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.

Condition Intervention Phase
Colorectal Cancer Ovarian Cancer Gastric Cancer Breast Cancer Lung Cancer Biological: Allogeneic whole epithelial tumor cells, DNP-conjugated and irradiated Phase 1 Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722228


Contacts
Contact: Arik , Tzukert, DMD : 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas , Lemberg, PhD 00 972 2 6777572 : lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Principal Investigator: Tamar Peretz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00722228     History of Changes
Other Study ID Numbers: 0359-08-HMO-CTIL
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: July 25, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Colorectal Neoplasms
Stomach Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases