Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
Condition: Leukemia
MeSH terms: Leukemia
Intervention: GM-K562 cell vaccine; Interferon alfa; Sargramostim
Intervention description: Given by injection; Given by injection; Given by injection
Intervention MeSH terms: Interferons; Interferon-alpha; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomly assigned to Arm A or Arm B and received up to twelve months of protocol therapy. If at any point a participant progressed, relapsed, or had unacceptable toxicity, they could cross over to the other arm. Participants could only cross over once.
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Philadelphia chromosome positive chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia

Summary:

      RATIONALE: Tyrosine kinase inhibitors 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-CSF may help cells that are involved in the body's immune response work better.
      Vaccines made from a person's cancer cells may help the body build an effective immune
      response to kill cancer cells.

      PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon
      alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine
      therapy in treating patients with chronic phase chronic myelogenous leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of chronic myelogenous leukemia (CML) in chronic phase based on cytogenetic
             detection of the Philadelphia chromosome and/or detection of the BCR-ABL rearrangement
             by any of the following molecular methods:

               -  Recombinant DNA analysis of the BCR-ABL fusion gene

               -  Fluorescence in situ hybridization (FISH)

               -  Polymerase chain reaction detection of the BCR-ABL hybrid mRNA

          -  Documentation of complete cytogenetic response by conventional cytogenetic or FISH
             analysis while on a stable dose of tyrosine kinase inhibitor

          -  No other phase of CML

        PATIENT CHARACTERISTICS:

          -  ECG performance status 0-2

          -  Life expectancy > 24 months

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Creatinine ≤ 2.0 mg/dL

          -  Bilirubin ≤ 2.0 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  No other malignancy within the past 5 years except in situ cervical carcinoma or
             adequately treated nonmelanoma skin cancer

          -  No other disease requiring long-term corticosteroids or immunosuppressants

        PRIOR CONCURRENT THERAPY:

          -  At least 28 days since prior investigational agents

          -  No prior bone marrow transplant or other transplant

          -  No concurrent immunosuppressants (e.g., steroids, cyclosporine, azathioprine,
             mycophenolate mofetil, sirolimus, or tacrolimus)

          -  No concurrent hydroxyurea, busulfan, or cytoreductive agents (other than frontline
             TKI)

          -  No other concurrent anticancer agents or therapies