Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

Phase 1

• Conditions: Melanoma; Colorectal Cancer; Ovarian Cancer; Gastric Cancer; Breast Cancer; Lung Cancer; Kidney Cancer
• Interventions: Biological: Autologous or Allogeneic tumor cells

• Registration Number: NCT00722228
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Status Verified: 2017-01
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous or Allogeneic tumor cells	Autologous or Allogeneic tumor cells	Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel