Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

NCT ID: NCT00722228

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2027-01-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Autologous or Allogeneic tumor cells

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

Group Type EXPERIMENTAL

Autologous or Allogeneic tumor cells

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hani Steinberg, R.N. B.A.

Role: CONTACT

: 00 972 50 7874292

Tamar Peretz, MD

Role: CONTACT

00 972 2 6777825

Other Identifiers

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0359-08-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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