Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Peptide Vaccine (PR1 Peptide); Peginterferon alfa-2b; Imatinib; GM-CSF
Intervention description: 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.; Continue receiving imatinib by mouth at the same dose received during the last 6 months.; 75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
Intervention MeSH terms: Peginterferon alfa-2b; Imatinib Mesylate; Vaccines; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Myelogenous Leukemia; Leukemia; Peptide Vaccine; PR1 Peptide; Imatinib; Gleevec; GM-CSF; Sargramostim; Leukine; Peginterferon alfa-2b; Peg-Intron

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.
    

Eligibility 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