Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

Drexel University

Status: Unknown

Conditions: Glioblastoma Multiforme; Astrocytoma Anaplastic Foci

Treatments: Drug: MAB-425 radiolabeled with I-125

Study type: Interventional

Funder types: Other

Identifiers

NCT01317888

1043323 (Other Identifier)

18508

Details and patient eligibility

About

The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).

Enrollment: 11 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 Years or Older
• 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

• Metastases or Second Primary Cancer
• Iodine allergy
• Inability to tolerate oral intake of Lugol's solution
• HIV Infection
• Positive HAMA test
• Pregnancy
• Uncontrolled Seizures

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

Treated with MAB-425

Experimental group

Description:

All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.

Treatment:

Drug: MAB-425 radiolabeled with I-125