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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
Oncovir, Inc. |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00795457 |
Purpose
This is a pilot vaccine study in adults with either WHO grade II astrocytoma or oligoastrocytoma. 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| 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 High-Risk WHO Grade II Astrocytomas and Oligo-Astrocytomas |
| 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 |
|---|---|
|
1: Experimental
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.
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2: Experimental
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.
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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| Contact: Frank Lieberman, MD | liebermanf@upmc.edu | |
| Contact: Rita Johnson, RN | (412) 692-2600 | johnsonr1@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| University of Pittsburgh Cancer Institute | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Frank Lieberman, MD 412-692-2600 liebermanf@upmc.edu | |
| Contact: Rita Johnson, RN 412-647-8571 johnsonr1@upmc.edu | |
| Principal Investigator: | Frank Lieberman, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh Cancer Institute ( Frank Lieberman ) |
| Study ID Numbers: | 07-057, R21CA133859-01A1 |
| Study First Received: | November 19, 2008 |
| Last Updated: | January 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00795457 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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vaccine WHO Grade II Astrocytoma WHO Grade II Oligo-Astrocytoma |
|
Interferon Inducers Neoplasms by Histologic Type Astrocytoma Immunologic Factors Physiological Effects of Drugs Neoplasms, Nerve Tissue Poly ICLC Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |