On vaccine made from patients' tumors

[posted by Predrag, notes on a treatment that Ed expressed interest in. Probably Barbara cannot join the trial, as it requires craniotomy, but otherwise the timing is right, and she is eligible. Would be good to contact Dr. Jeffrey Bruce, a surgeon at Columbia University Medical Center]

Research premise: Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

Dr. Andrew Parsa

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA
Contact: Valerie A Kivett, BS 415-353-2076 kivettv@neurosurg.ucsf.edu

heads the trial. He writes:

Immunotherapy is an attractive alternative to conventional adjuvant therapy because it can specifically target malignant glial cells while preserving function of surrounding cells, including neurons. Several clinical trials of active immunotherapy for malignant glioma patients have been initiated. [...] My laboratory has focused on the phenomenon of immunoresistance in cancer, and how immunoresistance relates to fundamental oncogenic events. [...] I have collaborated with a biotechnology company, Antigenics Incorporated, to develop an investigator initiated clinical trial to treat recurrent glioma patients with an autologous tumor derived heat shock protein vaccine. The phase I portion of this trial has finished accrual, and we have generated some favorable initial survival data as well as compelling immunomonitoring data. A multi-center Phase II study is currently underway for recurrent glioblastoma patients as well as a single center Phase II study evaluating the vaccine in primary glioblastoma patients treated with chemotherapy after radiation.

Parsa heads two clinical trials. The Phase 1 trial, running since 2006 and closed to accrual as of 7/25/2007, is the National Cancer Institute (NCI) funded "GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma"

One of the Co-PIs (Phase 1 only) is Jeffrey Bruce, MD

Herbert Irving Comprehensive Cancer Center (recruiting patients)
Columbia University Medical Center, New York
Contact: Candy Yanes cy2162@columbia.edu

The Phase 2 trial "HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM (HeatShock)" started June 2009, runs through 2011, is conducted ONLY in San Francisco.

Phase 2 trial eligibility:

• Able to read and understand the informed consent document; must sign the informed consent
• Histologically proven, non-progressive glioblastoma multiforme (GBM)
• Must have suspected diagnosis of Glioblastoma Multiforme with a surgical intent to resect at least 90% of enhancing disease
• Surgically accessible tumor for which surgical resection is indicated and has not been previously irradiated
• Prior radiotherapy required

Intervention:

• Conventional surgery craniotomy
• Patients undergo surgical resection. Viable tumor tissue is used to generate the gp96 heat shock protein-peptide complex (HSPPC-96) vaccine. Patients with primary disease receive standard adjuvant therapy after surgery. Patients whose disease progresses during or after standard adjuvant therapy receive the HSPPC-96 vaccine. Patients with recurrent disease receive the HSPPC-96 vaccine between 2-8 weeks after surgery. The HSPPC-96 vaccine is administered intradermally every 1-3 weeks for 4 doses and then every 2-3 weeks thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion.
• Patients are treated with the autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.

From a CNN article: "More than a year into the ongoing clinical trial, none of the eight patients who have received vaccines made from their tumors has seen cancer return."

A blog by Mino Freund, NASA Ames Research Center astrophysicist and a patient in Parsa's clinical trial, is worth a read. Stops July 2010.

Sara notes: also investigate treatment with Ativan.