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Recruiting NCT00722228

Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

Phase I / Phase II Interventional Colorectal Cancer Ovarian Cancer Gastric Cancer Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous or Allogeneic tumor cells.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Ovarian Cancer, Gastric Cancer, Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Israel · 1 center
  • Hadassah Medical Organization — Jerusalem

Identifiers

NCT: NCT00722228 · 0359-08-HMO-CTIL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗