RecruitingPhase 1Phase 2NCT00722228

Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors


Sponsor

Hadassah Medical Organization

Enrollment

50 participants

Start Date

Jul 1, 2008

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria3

  • Below 18 years of age
  • Women who are pregnant
  • Life expectancy of less than three months

Interventions

BIOLOGICALAutologous or Allogeneic tumor cells

Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.


Locations(1)

Hadassah Medical Organization

Jerusalem, Israel

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NCT00722228


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