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Clinical Trials

Developing the Future of Medicine

At JFK Medical Center, the following clinical trials have IRB approval for enrollment. JFK Medical Center is an Affiliate of the Rutgers Cancer Institute of New Jersey. As an Affiliate, access to other clinical trials is available.

Tocagen
511-13-01
A Phase I Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered Intravenously Prior to, and Intracranially  at the time of, Subsequent Resection for Recurrent High Grade Glioma and Followed by Treatment with Toca FC, Extended-Release 5FC

This is an open label study, ascending-dose trial of the safety and tolerability of increasing doses of Toca 511 administered intravenously to subjects with recurrent or progressive High Grade Glioma undergoing planned tumor resection. A portion of the total dose of Toca 511 is administered as a bolus injection approximately 11 days prior to resection. The remainder dose is administered intracranially. Approximately 6 weeks after surgery, the subjects will take oral 5-FC provided by the study.     

Tocagen
511-15-01
A Phase 2/3 Randomized Open Label Study of Toca 511, a Retroviral Replicating Vector, Combined wit Toca FC versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma

In this study, the Investigator has the choice of either single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence of glioblastoma or astrocytoma. Subjects will be randomized at the time of surgery in a 1:1 ratio. Crossover to the experimental arm is not allowed.
    
Tocagen
511-09-01
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

Subjects who participated in the primary study are offered the opportunity to continue in the investigational study. They have the option to continue with full or partial monitoring and also have the option to continue the investigational drug 5-FC or take no drug. This is the subject’s choice. If the subject has tumor recurrence or progression, repeat intracranial injection of Toca 511 followed by Toca FC may be offered.

ICT-121

Immunological targeting of CD-133 in recurrent glioblastoma: A multi-center Phase I translational and clinical study of an autologous CD-133 DC vaccine

Subjects who have first recurrence of glioblastoma and have undergone resection can participate if they are HLA A2+. The treatment consists of an autologous vaccine (made from each individual’s blood) once a week for 4 weeks, then once every 2 months.

ICT-107-301
A Phase III Randomized Double Blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy

Subjects must be HLA-A2 positive. There is a 1:1 randomization. There are 2 arms in this study. Arm 1 subjects will receive ICT-107 in combination with standard of care TMZ. Arm 2 subjects will receive standard of care TMZ with a blinded control consisting of autologous peripheral blood mononuclear cells.

Celldex
110-05
Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX110-05) for Newly Diagnosed and Recurrent GBM

Subject will be tested for a positive EGFRvIII. Plan is 2 priming doses and then monthly vaccine with GM-CSF. For recurrence, vaccine can be given with standard of care chemo. Each subject must be individually approved by the medical monitor of the study.

 



    
If you have any questions regarding any of the clinical trials, please call: Linda Thomas, RN (732) 321-7000, ext. 61689 or cell (732) 343-0111.