Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)

2014-08-27 03:40:58 | BioPortfolio


The goal of this clinical research study is to find out if using the PR1 peptide vaccine (PR1) without PEG-Intron® (interferon) or in combination with interferon can reduce or eliminate disease in patients who have CML that is in cytogenetic remission after treatment with imatinib mesylate, but who still have small amounts of disease able to be noticed (detected). Researchers want to see if giving low doses of interferon together with PR1 may make the vaccine more effective. The safety of treatment in this study will also be studied.


Your disease responded well to treatment with imatinib mesylate. It is in complete cytogenetic remission. This means that the Philadelphia chromosome (Ph), a change in genetic material that is believed to lead to leukemia, is no longer detectable (by the standard chromosome analysis) in your bone marrow and blood cells. A molecular remission, which is what researchers want you to achieve, means a greater reduction or a complete elimination of the Ph.

The small amounts of disease can be detected using a technique called polymerase chain reaction (PCR). This is a very powerful test that can detect very small amounts of disease that can still be present in the bone marrow and/or blood cells.

PR1 is an experimental vaccine made from a protein that is found in large amounts in leukemia cells in CML.

Imatinib mesylate (which you are already receiving as standard therapy) is designed to bind to certain proteins on the tumor cells, which may prevent the cells from growing.

Interferon is a drug that was used as standard therapy for patients with CML before imatinib mesylate was available. It can help the immune system to function more effectively (causing leukemia cells to show more PR1), which may make leukemia cells a better target to be killed.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will have your complete medical history recorded. You will have blood drawn (about 2 tablespoons) for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test. You will also have blood drawn (about 1 tablespoon) to see if you have the necessary protein (called HLA-A2) needed for the vaccine to recognize your cells. You will also have additional blood drawn (about 1 tablespoon) to test (using the PCR test) the levels of leukemia in your blood. You will have a bone marrow aspiration. To collect a bone marrow aspiration, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. You will have a chromosome test done on the number of chromosomes in your bone marrow (collected from your bone marrow aspiration). You will not have an additional procedure performed on you for this test. For this test, all of your chromosomes in 20 cells in your bone marrow will be counted to see if there may be any unhealthy changes (such as the Ph) present as well as how many may be present.

If you are found to be eligible to take part in this study, you will receive PR1 through a small needle just under your skin (subcutaneous injection). Imatinib mesylate will continue to be given to you by mouth at the dose that you are taking now as part of your standard therapy. PR1 will be mixed with a substance called Montanide ISA 51 VG, which is a regular procedure that will help your immune system respond to PR1.

You will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. Participants in one group will receive a subcutaneous injection of interferon with each PR1 vaccination. Participants in the other group will receive PR1 vaccination without interferon.

Regardless of what group you are assigned to, you will also receive, with each PR1 vaccination, a growth hormone called GM-CSF. The purpose of GM-CSF is to boost your immune system (in response to the PR1 vaccine) to help kill your leukemia. It is given as a subcutaneous injection in your arms or your thighs.

All participants will receive a total of 4 doses of the PR1 vaccine. The first 3 vaccinations are given every 3 weeks, and the last vaccination is given 18 weeks after the start of therapy in this study. You will receive all of these vaccinations at M. D. Anderson.

Every time you come in for an injection of PR1, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 2 tablespoons) for routine tests, and you will have blood drawn (about 1 tablespoon) for the PCR test. After you receive the last vaccination, you will continue having the PCR test every 3 months to test the level of leukemia in your blood and to see if your disease is responding to the vaccine. You will have a bone marrow aspiration at 1 month and 6 months after the last vaccination. To measure the response of your immune system to PR1, blood will be drawn (about 2 tablespoons each) before the first vaccination, at Weeks 6, 18, 22 and 6 months after treatment.

You will be taken off this study if intolerable side effects occur or your disease progresses (comes out of remission).

This is an investigational study. PR1 mixed with Montanide ISA-51 VG is authorized by the FDA for use in research only. Interferon and GM-CSF are FDA-approved and commercially available. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment




Peptide Vaccine (PR1 Peptide), Peginterferon alfa-2b, Imatinib


U.T. M.D. Anderson Cancer Center
United States


Active, not recruiting


M.D. Anderson Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:40:58-0400

Clinical Trials [5290 Associated Clinical Trials listed on BioPortfolio]

Patient-individualized Peptide Vaccination in Combination With Lenalidomide After First Line Therapy of CLL

The aim of this study is to induce a peptide-specific immune response in chronic lymphatic leukaemia (CLL) patients by multi-peptide vaccination with a patient-individualized peptide cockt...

Vaccine Therapy in Treating Patients With Metastatic Melanoma

RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with eithe...

Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine

The goal of this clinical research study is to find the best dosing schedule of a combined treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that may ...

A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1...

Imatinib Mesylate, Interferon Alfa, and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-C...

PubMed Articles [5059 Associated PubMed Articles listed on BioPortfolio]

An easy-to-use baseline scoring system to predict response to peginterferon alfa-2a in patients with chronic hepatitis B in resource-limited settings.

Approximately one-third of patients have durable responses after finite (48-week) treatment with peginterferon alfa-2a. The ability to identify patients likely to respond would be particularly useful ...

No association between IFNL3 (IL28B) genotype and response to peginterferon alfa-2a in HBeAg-positive or -negative chronic hepatitis B.

It has yet to be firmly established whether host IFNL3 (IL28B) genotype influences interferon responsiveness in patients with chronic hepatitis B. We investigated associations between single-nucleotid...

Complete functional mapping of infection- and vaccine-elicited antibodies against the fusion peptide of HIV.

Eliciting broadly neutralizing antibodies (bnAbs) targeting envelope (Env) is a major goal of HIV vaccine development, but cross-clade breadth from immunization has only sporadically been observed. Re...

Does switching to a second-generation tyrosine kinase inhibitor or increasing imatinib dose have long-term benefits in chronic myeloid leukemia patients with suboptimal responses under upfront standard-dose of imatinib?

ZNF224 is a transcriptional repressor of AXL in chronic myeloid leukemia cells.

ZNF224 is a KRAB-zinc finger transcription factor that exerts a key tumor suppressive role in chronic myelogenous leukemia. In this study, we identify the receptor tyrosine kinase Axl as a novel targe...

Medical and Biotech [MESH] Definitions

The production of PEPTIDES or PROTEINS by the constituents of a living organism. The biosynthesis of proteins on RIBOSOMES following an RNA template is termed translation (TRANSLATION, GENETIC). There are other, non-ribosomal peptide biosynthesis (PEPTIDE BIOSYNTHESIS, NUCLEIC ACID-INDEPENDENT) mechanisms carried out by PEPTIDE SYNTHASES and PEPTIDYLTRANSFERASES. Further modifications of peptide chains yield functional peptide and protein molecules.

A 36-amino acid peptide produced by the L cells of the distal small intestine and colon. Peptide YY inhibits gastric and pancreatic secretion.

The middle segment of proinsulin that is between the N-terminal B-chain and the C-terminal A-chain. It is a pancreatic peptide of about 31 residues, depending on the species. Upon proteolytic cleavage of proinsulin, equimolar INSULIN and C-peptide are released. C-peptide immunoassay has been used to assess pancreatic beta cell function in diabetic patients with circulating insulin antibodies or exogenous insulin. Half-life of C-peptide is 30 min, almost 8 times that of insulin.

A 27-amino acid peptide with histidine at the N-terminal and isoleucine amide at the C-terminal. The exact amino acid composition of the peptide is species dependent. The peptide is secreted in the intestine, but is found in the nervous system, many organs, and in the majority of peripheral tissues. It has a wide range of biological actions, affecting the cardiovascular, gastrointestinal, respiratory, and central nervous systems.

A pituitary adenylate cyclase-activating peptide receptor subtype found in LYMPHOCYTES. It binds both PACAP and VASOACTIVE INTESTINAL PEPTIDE and regulates immune responses.

More From BioPortfolio on "Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)"

Quick Search


Relevant Topic

Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

Searches Linking to this Trial