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Allogeneic Whole Cell Cancer Vaccine for Metastatic Epithelial Tumors

This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, July 2008

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00722228
  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 I
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Colorectal Cancer    Lung Cancer    Ovarian Cancer    Stomach Cancer   

U.S. FDA Resources

Study Type:   Interventional
  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    
      Jerusalem, Israel, 91120

Sponsors and Collaborators
Hadassah Medical Organization
  More Information


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

Study placed in the following topic categories:
Thoracic Neoplasms
Gonadal Disorders
Gastrointestinal Diseases
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Rectal Diseases
Genital Diseases, Female
Stomach Diseases
Respiratory Tract Diseases
Lung Neoplasms
Stomach Neoplasms
Breast Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Skin Diseases
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Stomach cancer
Intestinal Diseases
Intestinal Neoplasms
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Colorectal Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on October 24, 2008




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