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An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas


N/A
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme, Astrocytoma Anaplastic Foci

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Trial Information

An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prevention of disease progression

Outcome Description:

For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline

Outcome Time Frame:

3 months after first course with follow-up

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

18508

NCT ID:

NCT01317888

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Astrocytoma Anaplastic Foci
  • high grade gliomas of the brain
  • anti-body treatment
  • survival
  • Astrocytoma
  • Glioblastoma
  • Glioma

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