Autologous and Allogeneic Whole Cell Cancer Vaccine for M... | NCT00722228

Studies
Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

NCT00722228

Sponsor

Hadassah Medical Organization

Status

Recruiting

Last Update Posted

Oct 2, 2025Actual

Enrollment

50Estimated

Phase

Phase 1Phase 2

Conditions

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

Interventions

Autologous or Allogeneic tumor cells

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008Actual

Primary Completion Date

Mar 2025Actual

Completion Date

Jan 2027Estimated

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2025

Last Update Posted Date

Oct 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Autologous or Allogeneic tumor cells	Experimental	Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously.	Biological: Autologous or Allogeneic tumor cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous or Allogeneic tumor cells	Biological	Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hani Steinberg, R.N. B.A.	Contact	: 00 972 50 7874292		hanis@hadassah.org.il
Tamar Peretz, MD	Contact	00 972 2 6777825		tamary@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D010051	Ovarian Neoplasms
D013274	Stomach Neoplasms
D001943	Breast Neoplasms
D008175	Lung Neoplasms
D007680	Kidney Neoplasms
D008545	Melanoma

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided