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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
Oncovir, Inc. |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00795457 |
Purpose
In this research study, doctors will use an experimental tumor vaccine made from small molecules called peptides and Montanide ISA-51 (an oil-in-water emulsion). Most vaccines are preventative, meaning that they are given to healthy people to prevent infection with a particular microbe (germ), such as a virus or bacterium. They work by getting your immune system ready to act quickly against that microbe if it enters the body in the future. In contrast, the vaccine used in this study is therapeutic, meaning that it is made to treat a disease that you already have. In addition to protecting the body from outside invaders such as viruses and bacteria, the immune system has the ability to attack abnormal cells in the body, such as cancer cells. The goal of a cancer vaccine is to get your body to do that.
Although cancer cells seem to be the same as normal ones in most ways, scientists have found that they may make molecules not commonly found in the body, called tumor-associated antigens. The vaccine used in this study contains antigen peptides (pieces of protein) that are known to be expressed by glioma tumors. It is designed to help your immune system fight against your tumor and help to prevent or slow the growth of new brain tumor cells.
This vaccine will be given in combination with a study drug called Poly-ICLC (Polyinosinic-Polycytidylic acid with Polylysine and Carboxymethylcellulose). Poly-ICLC is a drug manufactured by Oncovir, Inc. It is also considered experimental and works in a similar way that the tumor vaccine does with your immune system. Poly-ICLC 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 purpose of this research study is to test the safety of this combination and to see how it affects your immune system.
This research study is considered experimental because neither the tumor vaccine nor the study drug, Poly-ICLC, has received approval from the Food and Drug Administration (FDA) for this use.
| 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.
|
|
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.
|
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 must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:
• Mild arthritis requiring NSAID medications
Participants who have another cancer diagnosis, except that the following diagnoses will be allowed:
Contacts and Locations| Contact: Hideho Okada, MD | (412) 623-1111 | okadah@upmc.edu |
| Contact: Teresa Donegan, PhD | (412) 647-8580 | donegante@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| University of Pittsburgh Cancer Institute | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Hideho Okada, MD 412-623-1111 okadah@upmc.edu | |
| Contact: Teresa Donegan, PhD (412) 647-8580 donegante@upmc.edu | |
More Information
| Responsible Party: | University of Pittsburgh Cancer Institute ( Hideho Okada, MD, PhD ) |
| Study ID Numbers: | 07-057, R21CA133859-01A1 |
| Study First Received: | November 19, 2008 |
| Last Updated: | January 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00795457 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |