Status:
COMPLETED
Super-Selective Intraarterial Cerebral Infusion Of Temozolomide (Temodar) For Treatment Of Newly Diagnosed GBM And AA
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Feinstein Institute for Medical Research
Hofstra North Shore
Conditions:
Glioblastoma Multiforme
Anaplastic Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits th...
Detailed Description
The current standard of care for newly diagnosed GBM is radiation therapy plus concomitant oral Temozolomide of doses of 75mg/m2 up to 150mg/m2. Because of the blood brain barrier (BBB) where drugs do...
Eligibility Criteria
Inclusion
- 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 (AOA).
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01180816
Start Date
August 1 2010
End Date
August 11 2020
Last Update
March 4 2021
Active Locations (1)
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1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10065