Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00722228
• Other study ID #: 0359-08-HMO-CTIL
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2008
• Est. completion date: January 2022

Study information

• Verified date: January 2017
• Source: Hadassah Medical Organization
• Contact: Hani Steinberg, R.N. B.A.
• Phone: : 00 972 50 7874292
• Email: hanis[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Gastric Cancer
• Kidney Cancer
• Kidney Neoplasms
• Lung Cancer
• Melanoma
• Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,