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

This study has been terminated.
(Vaccine sponsor ceased operations.)
Sponsor:
Collaborator:
The Vaccine Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00415857
First received: December 22, 2006
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Leukemia
Biological: Peptide Vaccine (PR1 Peptide)
Drug: Peginterferon alfa-2b
Drug: Imatinib
Drug: GM-CSF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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]

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Response rate is number of respondents compared to total participants. Blood draws to test polymerase chain reaction (PCR) every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.


Enrollment: 5
Study Start Date: December 2006
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PR1 + Imatinib
PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses. Continue receiving imatinib by mouth at the same dose received during the last 6 months. GM-CSF 75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
Biological: Peptide Vaccine (PR1 Peptide)
PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses.
Other Name: PR1 Vaccine
Drug: Imatinib
Continue receiving imatinib by mouth at the same dose received during the last 6 months.
Other Name: Gleevec
Drug: GM-CSF
75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
Other Names:
  • Sargramostim
  • LeukineTM
Experimental: PR1 + Imatinib + Interferon
PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses. Subcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination. GM-CSF 75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
Biological: Peptide Vaccine (PR1 Peptide)
PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses.
Other Name: PR1 Vaccine
Drug: Peginterferon alfa-2b
Subcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination.
Other Name: Peg-Intron
Drug: Imatinib
Continue receiving imatinib by mouth at the same dose received during the last 6 months.
Other Name: Gleevec
Drug: GM-CSF
75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
Other Names:
  • Sargramostim
  • LeukineTM

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients >/= 18 years with Philadelphia chromosome (Ph)- or BCR/ABLpositive CML (as determined by cytogenetics, FISH, or PCR).
  2. Patients must have received imatinib therapy for at least 18 months and not have increased their dose of imatinib in the last 6 months.
  3. Patients must be in complete cytogenetic remission.
  4. Patients must have detectable BCR-ABL transcript levels meeting at least one of the following criteria: 1) Patient has never achieved a major molecular response (i.e., never reached levels <0.05%), and transcript levels have shown in at least two consecutive measures separated by at least 1 month to have increased by any value, or
  5. continued from above: 2) Achieved a major molecular response that has been lost with an increase in transcript levels by at least 1-log over two consecutive analyses separated by at least 1 month, or 3) BCR-ABL transcript levels have reached a plateau defined as a ratio that is not more than 0.25-log (one fourth of a log) lower than the lowest value obtained in the last at least 6 months, with at least 2 values obtained during this period.
  6. Patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or any interruptions totaling 6 weeks within the 6 months prior to enrollment.
  7. Patients must be HLA-A2 positive at one allele
  8. Patients must give informed consent and sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
  9. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  10. Adequate organ function defined as: bilirubin <2 times upper limit of normal (ULN), creatinine <1.5 times ULN, and serum glutamate pyruvate transaminase (sGPT) <2.5 times ULN.
  11. Women of childbearing potential should practice effective methods of contraception.

Exclusion Criteria:

  1. Patients with a history or clinical evidence of autoimmune disorders
  2. Patients receiving immunosuppressive therapy including cyclosporine, or FK506 within 3 months of study entry
  3. Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug treatment (topical and inhaled corticosteroids are permitted)
  4. GM-CSF or interferon administration within 1 month of first PR1 injection
  5. Patients receiving any other investigational agents currently or within the past 4 weeks. Patients must have recovered from any adverse effects of investigational therapy.
  6. Patients who are pregnant or breast-feeding
  7. Patients with clinically significant heart disease (New York Heart Association (NYHA) Class III or IV)
  8. Patients with positive cANCA
  9. History of HIV positivity or AIDS
  10. Chloroma at time of study screening
  11. Prior vaccine therapy for Chronic myelogenous leukemia (CML)
  12. Known allergy to Montanide ISA-51 VG adjuvant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415857

Locations
United States, Texas
UT MD . Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
The Vaccine Company
Investigators
Principal Investigator: Jorge E. Cortes, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00415857     History of Changes
Other Study ID Numbers: 2006-0360
Study First Received: December 22, 2006
Last Updated: October 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Myelogenous Leukemia
Leukemia
Peptide Vaccine
PR1 Peptide
Imatinib
Gleevec
GM-CSF
Sargramostim
Leukine
Peginterferon alfa-2b
Peg-Intron

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Reaferon
Imatinib
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Alcohol Deterrents
Central Nervous System Agents
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014