Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00722228
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hadassah Medical Organization
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colorectal Cancer, Ovarian Cancer, Gastric Cancer, Breast Cancer, Lung Cancer, Kidney Cancer, Melanoma
Arms & Interventions

Arms

Experimental: Autologous or Allogeneic tumor cells

Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hadassah Medical Organization, Jerusalem 281184, Israel

Status

Recruiting

Address

Hadassah Medical Organization

Jerusalem 281184, , 91120

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