NCT00589706

Brief Summary

Data from the wistar institute indicated that this anti-body labeled with iodine-125 would localized in the tumor cells of high grade gliomas of the brain. the project combines surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II trial in this disease entity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1985

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1985

Completed
23 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

27.9 years

First QC Date

December 26, 2007

Last Update Submit

May 8, 2017

Conditions

Gliomas

Keywords

high grade gliomas of the brainanti-body treatmentsurvival

Outcome Measures

Primary Outcomes (1)

  • Survival

    Potential benefits may include improved long-term survival. All or part of your tumor may be destroyed. You may experience relief of symptoms related to your tumor.

    More than a year

Study Arms (1)

A

EXPERIMENTAL

All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections. The purpose of this protocol is to allow you to receive course(s) of 1251-MAB 425 until your brain tumor begins to grow, you develop side effects to the treatment, or your medical condition changes (ie: become affected with human immunodeficiency virus (HIV) or develop another cancer).

Drug: MAb-425

Interventions

MAb-425DRUG

MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all cases above 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hahneman Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (1)

  • Li L, Quang TS, Gracely EJ, Kim JH, Emrich JG, Yaeger TE, Jenrette JM, Cohen SC, Black P, Brady LW. A Phase II study of anti-epidermal growth factor receptor radioimmunotherapy in the treatment of glioblastoma multiforme. J Neurosurg. 2010 Aug;113(2):192-8. doi: 10.3171/2010.2.JNS091211.

    PMID: 20345222DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Luther W Brady, MD

    Drexel University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 10, 2008

Study Start

January 1, 1985

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)