Astrocytoma Anaplastic Foci, Glioblastoma Multiforme
Conditions
Keywords
high grade gliomas of the brain, anti-body treatment, survival
Brief summary
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).
Interventions
DRUGMAB-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.
Sponsors
Drexel University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of disease progression | 3 months after first course with follow-up | 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 results
None listed