Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

September 29, 2025 updated by: Hadassah Medical Organization
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization
        • Principal Investigator:
          • Tamar Peretz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2008

Primary Completion (Actual)

March 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimated)

July 25, 2008

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0359-08-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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