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|NCT01884740 : Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22|
|Phase||Phase 1/Phase 2|
|Ages||Min: 1 Year Max: 21 Years|
1. Male or female patients, under 22 years of age, with a documented histologic diagnosis
of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA),
fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or
anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed brainstem glioma
2. Patients must have at least one confirmed and evaluable tumor site.
*A confirmed tumor site is one in which is biopsy-proven with the exception of
brainstem glioma which will be eligible with radiographic diagnosis. NOTE:
Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing
lesions must have been performed within three weeks of treatment on this research
3. Patients must have a Karnofsky or Lansky performance status 70%. Karnofsky is used for
patients older than or equal to the age of 16 years and Lansky for those under 16
years old and an expected survival three months.
4. No chemotherapy for three weeks prior to treatment under this research protocol and no
external beam radiation for eight weeks prior to treatment under this research
5. Patients must have adequate hematologic reserve with absolute neutrophils greater than
or equal to 1000/mm3 and platelets greater than or equal 100,000/mm3.
6. Pre-enrollment chemistry parameters must show: bilirubin less than 1.5X the
institutional upper limit of normal (IUNL); AST or ALT less than 2.5X IUNL and
creatinine less than 1.5X IUNL.
7. Pre-enrollment coagulation parameters (PT and PTT) must be less than 1.5X the IUNL.
8. Concomitant Medications:
Growth factor(s): Must not have received within 1 week of entry onto this study.
Steroids: Systemic corticosteroid therapy is permissible in patients with CNS tumors
for treatment of increased intracranial pressure or symptomatic tumor edema. Patients
with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose
for at least 1 week prior to study entry.
9. Patients of reproductive age must agree to use a medically effective method of
contraception during and for a period of three months after the treatment period. A
pregnancy test will be performed on each premenopausal female of childbearing
potential immediately prior to entry into the research study.
10. Patients or their parents/guardians must be able to understand and give written
informed consent. Informed consent must be obtained at the time of patient screening.
11. Because of known concerns with Avastin and wound healing, craniotomy patients are
eligible for the treatment if they have had a craniotomy greater than two weeks prior
to IA therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4
weeks. Minor surgeries may be performed after two weeks.
1. Previous treatment with Avastin and Cetuximab
2. Females who are pregnant or lactating.
3. Females of childbearing potential and fertile men will be informed as to the potential
risk of procreation while participating in this research trial and will be advised
that they must use effective contraception during and for a period of three months
after the treatment period. If they do not agree, they will be ineligible for the
4. Patients with significant concurrent medical or psychiatric conditions that would
place them at increased risk or affect their ability to receive or comply with
treatment or post-treatment clinical monitoring.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01884740
| Link to official Clinicaltrials.gov listing