Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01269853 · ClinicalTrials.gov registry record · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
A Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT01269853: Recruiting Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, sponsored by Northwell Health.
NCT01269853 is a Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 54 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01269853, a Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study 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 the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of either surgical resection, external beam radiation or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators have shown in a previous phase I trial that a single Super-selective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that trial in that the investigators seek to test the hypothesis that repeated dosing of intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab to improve progression free and overall survival. The investigators expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to the patients in the near future.
Primary Outcome
We will determine this composite overall response rate (CORR) through the Response Assessment in Neuro-Oncology (RANO) criteria
Conditions Studied
Interventions
- DRUG Bevacizumab
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2010-10 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
What NCT01269853 shows while recruiting
NCT01269853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (44% lower).
The record links to 2 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Bevacizumab is the first listed.
NCT01269853 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01269853 about?
NCT01269853 is a clinical study titled "Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA". 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 the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for G...
What is the current status of trial NCT01269853?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2010-10. Estimated completion is 2027-10.
What conditions does trial NCT01269853 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Anaplastic Astrocytoma.
What interventions are being tested in trial NCT01269853?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT01269853?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01269853 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma Multiforme
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01269853's enrollment target sits among peer trials
54 34th of 88 higher than 55 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
RECRUITING · Phase 1
-
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
RECRUITING · Phase 1
-
Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
RECRUITING · Phase 1
-
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
RECRUITING · Phase 1
-
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
RECRUITING · Phase 1
-
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
- NCT03081910 · 54 participants · Phase 1
Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia