Clinical Trials

Phase II Trial of EGFRvIII Vaccine in the Treatment of Newly Diagnosed Glioblastoma Multiforme (GBM)

New clinical trial at Mount Sinai Comprehensive Brain Tumor Center for newly diagnosed glioblastoma multiforme (GBM): Phase II Trial of EGFRvIII Vaccine in the Treatment of Newly Diagnosed Glioblastoma Multiforme (GBM)

Glioblastoma is a kind of malignant brain tumor that has a poor prognosis. Expression of the EGFRvIII mutation of the EGFR confers an even worse prognosis in GBM than usual. The initial clinical study of this vaccine in humans demonstrated a significant survival advantage. The Phase II trial is now beginning at the Mount Sinai Comprehensive Brain Tumor Center. Potential patients must not have had any other tumor treatment.

Candidates for the study include:

• Patients with a presumed diagnosis of GBM who have not had surgery
• Patients who have had surgery and have insignificant residual tumor after the surgery
• Patients with significant post-operative residual tumor might qualify if they have the potential for a >95% tumor resection by our neurosurgeons. 

Candidate patients require pre-operative consent to assay for the presence of the EGFRvIII mutation in the tumor tissue. Unstained or archived paraffin embedded brain tumor tissue may also qualify if the surgery has accomplished or has the potential to accomplish a >95 percent tumor resection (very strict post-operative MRI criteria must be satisfied). If patients have the EGFRvIII mutation they are randomized to receive conformal radiation, chemotherapy, and the experimental vaccine or to the control group (conformal radiation and chemotherapy only) at a 2:1 ratio to the experimental treatment arm. The experimental vaccine is continued on a monthly basis, but will be discontinued if the tumor relapses. 

If you have questions or have a patient who you think might qualify, please call Principal Investigator, Robert Aiken, M.D., at (212) 241-4503 or e-mail him as soon as possible at robert.aiken@mssm.edu.  Entry into the trial is time sensitive.

Phase I Trial of MPC-6827 and Carboplatin for the Management of Relapsed Glioblastoma Multiforme

MPC-6827 is a drug that has a novel mechanism of action and is being studied here in patients who have relapsed or progressive glioblastoma. This unique drug reaches a concentration 20-fold greater in brain tumor tissue than in blood and appears to be unusually effective in shrinking tumors in experimental animals. When used with a platinum based drug like carboplatin, there appears to be a synergetic response promoting an anti-tumor response. Appropriate patients for this protocol are individuals with glioblastoma who have not responded to Temodar and radiation. Prospective patients do not require further surgery but need to meet certain performance and health minima.

If you think that you may have an appropriate patient, please call Robert Aiken, M.D. at (212) 241-4503.

Brain tumor article by Dr. Germano from Our Town and West Side Spirit, November 2002.