Trial record 4 of 14 for: HSPPC-96

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2016 by Ann & Robert H Lurie Children's Hospital of Chicago

Sponsor:

Information provided by (Responsible Party):

Ann & Robert H Lurie Children's Hospital of Chicago

ClinicalTrials.gov Identifier:

NCT02722512

First received: March 17, 2016

Last updated: July 28, 2016

Last verified: July 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Glioblastoma Multiforme Astrocytoma, Grade III Anaplastic Ependymoma Clear Cell Ependymoma Ependymoma	Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96) Procedure: Tumor Resection Radiation: Radiation	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 Intracranial High Grade Glioma and Ependymoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Shock

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Ependymoma Anaplastic Ependymoma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	20
Study Start Date:	July 2016
Estimated Study Completion Date:	May 2019
Estimated Primary Completion Date:	May 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Newly Diagnosed High Grade Glioma (HGG) Heat Shock Protein Peptide Complex-96 (HSPPC-96) therapy will be given between 0-28 days after the completion of radiation therapy (XRT) AND no more than 60 days from completion of XRT. Vaccine will be given once weekly for 4 weeks. The 4 weeks (28 days) of vaccine administration will be followed by four weeks (28 days) of observation. In patients with sufficient vaccine (on both Arms A and B), a maintenance therapy will be instituted. It will be administered at the same dose the patient was enrolled at and given every 2 weeks until vaccine is exhausted or there is evidence of tumor progression. The first dose of maintenance vaccine should be administered between day 0-14 (and no greater than 28 days) after completion of the 28 days observation period.	Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96) The vaccine is patient specific, created from the patient's own brain tumor resected at a clinically necessary surgery. The vaccine is administered intradermally on a weekly basis. Procedure: Tumor Resection Clinically-indicated removal of the tumor Radiation: Radiation Focal Radiation Therapy
Experimental: Recurrent HGG and Ependymoma On Arm B, Heat Shock Protein Peptide Complex-96 (HSPPC-96) will be given as soon as possible after tumor resection post-operative recovery and sufficient time for vaccine preparation (typically 0-28 days post-operatively) AND no more than 60 days post-operatively. Vaccine will be given once weekly for 4 weeks. These 4 weeks (28 days) of vaccines will be followed by four weeks (28 days) of observation. In patients with sufficient vaccine, a maintenance therapy will be given. It will be given at the same dose the patient was enrolled at and given every 2 weeks until vaccine is exhausted or there is evidence of tumor progression. The first dose of maintenance vaccine should be given between day 0-14 (and no greater than 28 days) after completion of the 28 days observation period.	Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96) The vaccine is patient specific, created from the patient's own brain tumor resected at a clinically necessary surgery. The vaccine is administered intradermally on a weekly basis. Procedure: Tumor Resection Clinically-indicated removal of the tumor

Arms

Assigned Interventions

Experimental: Newly Diagnosed High Grade Glioma (HGG)

Heat Shock Protein Peptide Complex-96 (HSPPC-96) therapy will be given between 0-28 days after the completion of radiation therapy (XRT) AND no more than 60 days from completion of XRT. Vaccine will be given once weekly for 4 weeks. The 4 weeks (28 days) of vaccine administration will be followed by four weeks (28 days) of observation. In patients with sufficient vaccine (on both Arms A and B), a maintenance therapy will be instituted. It will be administered at the same dose the patient was enrolled at and given every 2 weeks until vaccine is exhausted or there is evidence of tumor progression. The first dose of maintenance vaccine should be administered between day 0-14 (and no greater than 28 days) after completion of the 28 days observation period.

Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96)

The vaccine is patient specific, created from the patient's own brain tumor resected at a clinically necessary surgery. The vaccine is administered intradermally on a weekly basis.

Procedure: Tumor Resection

Clinically-indicated removal of the tumor

Radiation: Radiation

Focal Radiation Therapy

Experimental: Recurrent HGG and Ependymoma

On Arm B, Heat Shock Protein Peptide Complex-96 (HSPPC-96) will be given as soon as possible after tumor resection post-operative recovery and sufficient time for vaccine preparation (typically 0-28 days post-operatively) AND no more than 60 days post-operatively. Vaccine will be given once weekly for 4 weeks. These 4 weeks (28 days) of vaccines will be followed by four weeks (28 days) of observation. In patients with sufficient vaccine, a maintenance therapy will be given. It will be given at the same dose the patient was enrolled at and given every 2 weeks until vaccine is exhausted or there is evidence of tumor progression. The first dose of maintenance vaccine should be given between day 0-14 (and no greater than 28 days) after completion of the 28 days observation period.

Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96)

The vaccine is patient specific, created from the patient's own brain tumor resected at a clinically necessary surgery. The vaccine is administered intradermally on a weekly basis.

Procedure: Tumor Resection

Clinically-indicated removal of the tumor

Show Detailed Description

Eligibility


Ages Eligible for Study:	3 Years to 21 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Arm A: Newly Diagnosed High Grade Glioma Tumor
Arm B: Recurrent, resectable High Grade Glioma or Ependymoma
Stable Neurologic Status
Lanksy/Karnofsky score greater than or equal to 50.
Adequate Bone Marrow Function (ANC≥ 1000/μL, platelets≥ 100,000/μL transfusion independent, Hemoglobin ≥ 8.0 gm/dL with or without transfusion support)
Adequate Liver Function (Bilirubin ≤ 2x institutional normal for age, Alanine transaminase (ALT) ≤ 5x institutional normal for age, Aspartate Aminotransferase (AST) ≤ 5x institutional normal for age)
Adequate Renal Function (Normal creatinine for age and/or glomerular filtration rate ≥ 70 mls/min/1.73 m2)
Female patients of childbearing potential must have a negative serum or urine pregnancy test

Exclusion Criteria:

Patients with unresectable disease are not eligible.
Patients with primary spinal cord tumors are not eligible.
Patients with metastatic disease are not eligible for Arm A (this does NOT apply to Arm B).
Patients with a known allergy to any component of the vaccine or any compounds of similar chemical or biologic composition of the vaccine are not eligible.
Patients with known auto-immune disease are excluded.
Patients with known immunodeficiency are excluded.
Patients with a concurrent malignancy are excluded.
Clinically Significant Concurrent Illness
Patients receiving any other anticancer or investigational drug
Patients with uncontrolled seizure disorders
Patients whose central nervous system (CNS) tumor is considered a secondary malignancy from prior therapies

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02722512

Contacts


Contact: Jason Fangusaro, MD	312-227-4090	jfangusaro@luriechildrens.org

Locations


United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago	Recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Golbeck, BS 312-227-4858 egolbeck@luriechildrens.org
Sub-Investigator: Stewart Goldman, MD
Sub-Investigator: Rishi Lulla, MS, MD
Sub-Investigator: Natasha Pillay-Smiley, DO

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators


Principal Investigator:	Jason Fangusaro, MD	Ann and Robert H. Lurie Childrens Hospital of Chicago

More Information


Responsible Party:	Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:	NCT02722512 History of Changes
Other Study ID Numbers:	2016-362
Study First Received:	March 17, 2016
Last Updated:	July 28, 2016
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration
Individual Participant Data
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:


Glioblastoma Astrocytoma Ependymoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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