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Allogeneic Whole Cell Cancer Vaccine for Metastatic Epithelial Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00722228
First received: July 23, 2008
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00722228     History of Changes
Other Study ID Numbers: 0359-08-HMO-CTIL
Study First Received: July 23, 2008
Last Updated: July 24, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 16, 2013