Clinical Trial: Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I and Feasibility Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Pediatric Patients With Newly Diagnosed Intracranial High Grade Glioma and Recurrent Resectable Intracra

Brief Summary: The purpose of this study is to determine whether Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine is an feasible and safe treatment for pediatric patients with newly-diagnosed High-Grade Gliomas or recurrent, resectable High-Grade Gliomas and Ependymomas.

Detailed Summary:

Immunotherapy for Brain Tumors:

Although it is usually ineffective alone, it has long been recognized that the immune system of tumor bearing hosts (human and animal models) does, indeed, mount an endogenous immune-mediated response to tumor. Unfortunately, this immune response alone is not sufficient in combating tumor. The balance of immune response and immune regulation often mitigates this anti-tumor response. Several mechanisms within tumor-bearing hosts compromise the efficacy of this anti-tumor immune response, including low levels of expression of co-stimulatory molecules such as the B7 family of immune-regulatory ligands, the tumor's local production of immunosuppressive factors and the tumor's ability to over-express pro-survival factors thus escaping destruction by the host immune system. However, many have hypothesized that if this immune response can be better harnessed and/or magnified, there is potential for heightened tumor responses.

A number of specific observations support the use of immunotherapy to treat brain tumors. Data published supports a possible correlation between HIV mediated immunosuppression and the development of intracranial glial tumors. Immunosuppression in transplant recipients has also been implicated in the development of intracranial glioma. Further supporting this hypothesis are documented rare cases of long-term remission of malignant brain tumors following significant post-operative infection. These observations have fueled the idea that a heightened immune system may confer some protection against intracranial tumors. With this in mind, one hypothesis is that successful active immunotherapy for patients with brain tumors will require development of a specific peptide or polyvalent vaccines in an effort to further stimulate the host's immune system against specific tumor-associate
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome: The rolling 6 statistical design will be utilized to establish the MTD and RP2D of HSPCC autologous vaccine in children with newly diagnosed high grade glioma (HGG) following focal radiation therapy and in recurrent HGG and ependymoma given alone. [ Time Frame: 36 months ]

Original Primary Outcome:

  • The feasibility of vaccine creation from pediatric tumors based on the volume of tumor resected at the time of surgery compared to the volume needed for adult patients (7 grams) [ Time Frame: 36 months ]
  • Toxicity and safety of HSPCC-96 in children thereby recommending the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) based on number of participants with treatment-related adverse events as assessed by the CTCAE v4.0 [ Time Frame: 36 months ]


Current Secondary Outcome:

  • To estimate the progression-free survival distribution in children with recurrent and resectable HGG treated with HSPPC-96 vaccine therapy alone (Arm B). [ Time Frame: 60 months ]
  • To estimate the progression-free survival distribution in children with recurrent and resectable ependymoma treated with HSPPC-96 vaccine therapy alone (Arm B). [ Time Frame: 60 months ]
  • To evaluate patient immune responses as measured by intracellular cytokine staining and peripheral blood immune correlates in the above patient groups. [ Time Frame: 60 months ]


Original Secondary Outcome:

  • The progression-free survival distribution in children with newly diagnosed resectable HGG treated with focal radiation (XRT) followed by HSPPC-96 vaccine therapy (Arm A). [ Time Frame: 60 months ]
  • The progression-free survival distribution in children with recurrent and resectable HGG and Ependymoma treated with HSPPC-96 vaccine therapy alone (Arm B). [ Time Frame: 60 months ]


Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: March 17, 2016
Date Started: July 2016
Date Completion: May 2019
Last Updated: July 28, 2016
Last Verified: July 2016