Immunotherapy of Cancer Using Donor Lymphocytes Labelled... | NCT00149019

Studies
Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

NCT00149019

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Apr 8, 2011Estimated

Enrollment

12Estimated

Phase

Phase 2

Conditions

Metastatic Solid Tumors

Interventions

Cell therapy with bispecific antibodies

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the PI is no longer work at Hadassah

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Not provided

Completion Date

Sep 2005Estimated

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

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

Apr 7, 2011

Last Update Posted Date

Apr 8, 2011Estimated

Description Module

Brief Summary

Patients with resistant metastatic solid tumors failing all conventional modalities who are eligible for immunotherapy by bispecific antibodies.

First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or EpCAM with residual or recurrent disease following NST will be candidates for donor lymphocytes immunotherapy using bispecific antibodies.

Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cell therapy with bispecific antibodies	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Secondary Outcomes

Measure	Description	Time Frame
To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with metastatic solid tumors expressing Her-2/Neu or EpCAM, with available match donor for NST.
Patients with metastatic solid tumors not expected to be cured failing available conventional modalities, age >18, with no upper age limit.
Patients with metastatic breast cancer failing treatment with Herceptin.
Patients with metastatic cancer cells expressing Her-2/Neu or EpCAM.
Patients with evidence of disease following allogeneic stem cell transplantation with tumor cells expressing Her-2/Neu or EpCAM.
Karnofsky performance status >60%
Life expectancy > 3 months, to be able to assess response.

Exclusion Criteria:

Patients not fulfilling any of the above.
Patients with active or ongoing infection that may endanger their life, whenever immunosuppression may be counter-indicated.
Pregnant or lactating women.
Patients positive for HIV.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shimon Slavin, MD	Hadassah Medical Organization	Principal Investigator

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D064987	Cell- and Tissue-Based Therapy
D018033	Antibodies, Bispecific

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided