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

First Received: July 23, 2008 Last Updated: July 24, 2008 History of Changes

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

Study Type:

Interventional

Resource links provided by NLM:

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

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

No publications provided

Study ID Numbers:	0359-08-HMO-CTIL
Study First Received:	July 23, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00722228 History of Changes
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
Ovarian Cancer
Breast Diseases
Endocrine Gland Neoplasms

Digestive System Neoplasms
Ovarian Neoplasms
Skin Diseases
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Intestinal Diseases
Intestinal Neoplasms
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Stomach Cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Thoracic Neoplasms
Gonadal Disorders
Gastrointestinal Diseases
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Rectal Diseases
Genital Diseases, Female
Neoplasms by Site
Stomach Diseases
Respiratory Tract Diseases
Lung Neoplasms
Stomach Neoplasms
Breast Diseases
Endocrine Gland Neoplasms

Respiratory Tract Neoplasms
Digestive System Neoplasms
Ovarian Neoplasms
Skin Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Adnexal Diseases
Neoplasms
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009