Clinical Trial Details
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NCT01180816 : Super-Selective Intraarterial Cerebral Infusion Of Temozolomide (Temodar) For Treatment Of Newly Diagnosed GBM And AA
PhasePhase 1
AgesMin: 18 Years Max: N/A
Criteria for Inclusion:

- Male or female patients of ?18 years of age.

- Patients with a documented histologic diagnosis of newly diagnosed or glioblastoma
multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma

- Patients must have at least one confirmed and evaluable tumor site.?

*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic
procedures (e.g., Gad-enhanced MRI or CT scans) documenting existing lesions must
have been performed within three weeks of treatment on this research study.

- Patients must have a Karnofsky performance status ?60% (or the equivalent ECOG level
of 0-2) and an expected survival of ? three months.

- No other chemotherapy for two weeks prior to treatment under this research protocol

- Patients must have adequate hematologic reserve with WBC?3000mm3, absolute
neutrophils ?1500mm3 and platelets ?100,000 mm3. Patients who are on Coumadin must
have a platelet count of ?150,000 mm3

- Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper
limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.

- Pre-enrollment coagulation parameters (PT and PTT) must be ?1.5X the IUNL.

- 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.

- Patients 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.

- Patients on steroids must receive prophylaxis for PCP pneumonia with Bactrim, unless
they have a history of allergy to sulfa drugs.

- Patients must be able to understand and give written informed consent. Informed
consent must be obtained at the time of patient screening.

Exclusion Criteria:

- Women who are pregnant or lactating.

- Subjects who decline birth control. Women 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.

- Patients with significant intercurrent 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.
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