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Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

Primary Purpose

Colorectal Cancer, Ovarian Cancer, Gastric Cancer

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Autologous or Allogeneic tumor cells

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hadassah Medical OrganizationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous or Allogeneic tumor cells

Arm Description

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00722228

First Posted

July 23, 2008

Last Updated

September 10, 2019

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00722228

Brief Title

Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Autologous or Allogeneic tumor cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Autologous or Allogeneic tumor cells

Intervention Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hani Steinberg, R.N. B.A.

Phone

: 00 972 50 7874292

hanis@hadassah.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Tamar Peretz, MD

Phone

00 972 2 6777825

tamary@hadassah.org.il

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamar Peretz, MD

12. IPD Sharing Statement

Learn more about this trial

Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

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