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Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

This study is currently recruiting participants.
Verified January 2017 by Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722228
First Posted: July 25, 2008
Last Update Posted: November 30, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
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 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.

Condition Intervention Phase
Colorectal Cancer Ovarian Cancer Gastric Cancer Breast Cancer Lung Cancer Kidney Cancer Melanoma Biological: Autologous or Allogeneic tumor cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous or Allogeneic tumor cells
Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously.
Biological: Autologous or Allogeneic tumor cells
Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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: Hani Steinberg, R.N. B.A. : 00 972 50 7874292 hanis@hadassah.org.il
Contact: Tamar Peretz, MD 00 972 2 6777825 tamary@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Principal Investigator: Tamar Peretz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Hadassah Medical Organization
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: November 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Stomach Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type