Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00415857|
Recruitment Status : Terminated (Vaccine sponsor ceased operations.)
First Posted : December 25, 2006
Results First Posted : April 30, 2014
Last Update Posted : April 30, 2014
|First Submitted Date ICMJE||December 22, 2006|
|First Posted Date ICMJE||December 25, 2006|
|Results First Submitted Date||March 28, 2014|
|Results First Posted Date||April 30, 2014|
|Last Update Posted Date||April 30, 2014|
|Start Date ICMJE||December 2006|
|Primary Completion Date||September 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Molecular Response Rate [ Time Frame: Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period. ]
Molecular response rate is number of respondents compared to total participants. Molecular Response is defined as a greater than a one-log reduction of Breakpoint Cluster Region-Abelson Murine Leukemia (BCR-ABL) transcript levels by quantitative polymerase chain reaction (PCR) from the baseline level at the time vaccination was initiated, or a disappearance of BCR-ABL transcripts, as measured by reverse transcription polymerase chain reaction (RT-PCR), occurring within 6 months from the last vaccination. Participants receive a series of 4 vaccinations administered at 3-week intervals and the fourth (final) vaccination administered 3 months after the third vaccination with blood draw to test PCR following every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00415857 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Number of Participants With Immunologic Response [ Time Frame: Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). ]
Immunologic Response (immune response) is defined as an increase of ≥ 0.5 PR1-HLA-A2 [human leukocyte antigen-A2 (HLA-A2)] tetramer cells / μl at the time of either the 3rd or 4th vaccination compared to the pre study absolute PR1-HLA-A2 tetramer cells / μl. Participants receive a total of 4 vaccinations over a period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). Participants assessed after 3rd and 4th vaccination for immunologic response.
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)|
|Official Title ICMJE||Potential of Immunotherapy to Convert a Complete Cytogenetic Remission in Chronic Myelogenous Leukemia to a Molecular Complete Remission: Randomized Phase II Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and Peginterferon Alfa-2b [PEG-INTRON(R), Schering Corporation]|
|Brief Summary||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 Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Completion Date||September 2013|
|Primary Completion Date||September 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00415857|
|Other Study ID Numbers ICMJE||2006-0360|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||M.D. Anderson Cancer Center|
|Study Sponsor ICMJE||M.D. Anderson Cancer Center|
|Collaborators ICMJE||The Vaccine Company|
|PRS Account||M.D. Anderson Cancer Center|
|Verification Date||March 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP