Super-Selective Intraarterial Cerebral Infusion Of Temozolomide (Temodar) For Treatment Of Newly Diagnosed GBM And AA
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ClinicalTrials.gov Identifier: NCT01180816 |
Recruitment Status :
Completed
First Posted : August 12, 2010
Last Update Posted : March 4, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Multiforme Anaplastic Astrocytoma | Drug: Super-Selective Intraarterial Intracranial Infusion of Temozolomide | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Trial of Super-Selective Intraarterial Cerebral Infusion of Temozolomide (Temodar) for Treatment of Newly Diagnosed Glioblastoma Multiforme and Anaplastic Astrocytoma |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | August 11, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Temozolomide (Temodar) |
Drug: Super-Selective Intraarterial Intracranial Infusion of Temozolomide
A single dose of Intraarterial Mannitol to open the blood brain barrier followed by Intra-arterial Temozolomide single dose (starting at 75mg/m2 and up to 250mg/m2) |
- Determine the safety of superselective intra-arterial cerebral infusion of Temozolomide up to a dose of 250 mg/m2 IA. [ Time Frame: 2 years ]
- Composite overall response rate. [ Time Frame: 2 years ]
- Six-month progression-free survival (PFS) and overall survival (OS) [ Time Frame: throughout the study. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180816
United States, New York | |
Lenox Hill Brain Tumor Center | |
New York, New York, United States, 10065 |
Responsible Party: | John Boockvar, MD Zucker SOM @Hofstra/Northwell, Professor, Feinstein Institute for Medical Research |
ClinicalTrials.gov Identifier: | NCT01180816 |
Other Study ID Numbers: |
14-292A |
First Posted: | August 12, 2010 Key Record Dates |
Last Update Posted: | March 4, 2021 |
Last Verified: | March 2021 |
GBM AA AO Brain Tumors |
Malignant Glioblastoma Multiforme Anaplastic Astrocytoma |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |