Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas
NCT ID: NCT01317888
Last Updated: 2011-03-17
Study Results
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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UNKNOWN
NA
11 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treated with MAB-425
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
MAB-425 radiolabeled with I-125
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.
Interventions
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MAB-425 radiolabeled with I-125
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.
Eligibility Criteria
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Inclusion Criteria
* Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
* Karnofsky performance status \> 70%
* Hemoglobin \> 10.0 g/dL, White Blood Cells \> 4,000/mm3, Platelets \> 100,000/mm3, BUN \< 25 mg/dL, Creatinine \< 1.5 mg/dL
* Signed informed consent
* Pathologic confirmation of GBM or AAF
* A negative beta hCG test for women of childbearing potential
* Negative HAMA test
Exclusion Criteria
* Iodine allergy
* Inability to tolerate oral intake of Lugol's solution
* HIV Infection
* Positive HAMA test
* Pregnancy
* Uncontrolled Seizures
18 Years
ALL
No
Sponsors
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Drexel University
OTHER
Responsible Party
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Drexel University College of Medicine
Other Identifiers
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1043323
Identifier Type: OTHER
Identifier Source: secondary_id
18508
Identifier Type: -
Identifier Source: org_study_id
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