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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
Oncovir, Inc. |
| Information provided by (Responsible Party): | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00795457 |
Purpose
This is a pilot vaccine study in adults with either WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in combination with the study drug Poly-ICLC.
Poly-ICLC, manufactured by Oncovir, Inc., has already been received and generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases.
The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted in each of two patient cohorts.
| Condition | Intervention | Phase |
|---|---|---|
|
Astrocytoma Oligo-Astrocytoma Glioma |
Biological: GAA/TT-peptide vaccine and poly-ICLC |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Bi-Institutional Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With WHO Grade II Low-Grade Gliomas |
| Estimated Enrollment: | 6 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients must have undergone surgery or biopsy alone ≤16 weeks prior to study entry (no postoperative radiation or chemotherapy).
|
Biological: GAA/TT-peptide vaccine and poly-ICLC
Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
|
|
Experimental: 2
Patients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery), which was completed ≥6 months prior to enrollment, and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression.
|
Biological: GAA/TT-peptide vaccine and poly-ICLC
Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
|
All patients on the study will be followed for a minimum of 2 years, so that the actual 2-year overall survival (OS) and progression-free survival (PFS) rates can be determined in an exploratory manner.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concurrent treatment or medications including:
Participants who have another cancer diagnosis, except that the following diagnoses will be allowed:
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1030 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Principal Investigator: | Frank Lieberman, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00795457 History of Changes |
| Other Study ID Numbers: | 07-057, R21CA133859-01A1 |
| Study First Received: | November 19, 2008 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
vaccine WHO Grade II Astrocytoma WHO Grade II Oligo-Astrocytoma |
|
Astrocytoma Glioma Oligodendroglioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Poly ICLC Interferon Inducers Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |