vaccine therapy in treating patients with philadelphia chromosome-positive chronic myelogenous leukemia

Conditions: Leukemia

Summary: rationale: vaccines made from peptides may help the body build an effective immune response to kill cancer cells. colony-stimulating factors, such as gm-csf, may increase the number of immune cells found in bone marrow or peripheral blood. giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. purpose: this phase ii trial is studying how well vaccine therapy works in treating patients with philadelphia chromosome-positive chronic myelogenous leukemia.

objectives: primary * determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (cmlvax100), in terms of peripheral blood bcr-abl/abl ratio reduction, in patients with philadelphia chromosome-positive chronic myelogenous leukemia. secondary * determine the reduction of molecular residual disease at 3 months in patients treated with this vaccine. * determine the reduction of molecular residual disease at 12 months in patients treated with maintenance boosts of this vaccine. * determine the rate of complete molecular response at any time after vaccination. * determine in vivo and in vitro peptide-specific immune response induced by the vaccine. outline: this is a prospective, nonrandomized, open-label, multicenter study. patients receive sargramostim (gm-csf) subcutaneously (sc) on days 1 and 2 and bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (cmlvax100) sc on day 2. treatment repeats every 2 weeks for 6 courses. patients then receive cmlvax100 sc once monthly for 3 months and then once every 3 months for 6 months (for a total of 1 year). patients may receive additional cmlvax100 sc every 6 months for at least 3 years. treatment continues in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 69 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of chronic myelogenous leukemia (cml) meeting the following criteria: * philadelphia chromosome positive disease * b3a2 breakpoint mutation * prior treatment with conventional imatinib mesylate for ≥ 18 months required * complete cytogenetic response documented on ≥ 2 different examinations * persistence of molecularly detectable residual disease (any level of bcr-abl transcript) * patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment patient characteristics: * who performance status 0-1 * bilirubin ≤ 2 times upper limit of normal (uln) * ast and alt ≤ 2.5 times uln * creatinine ≤ 1.5 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no severe active infection or other serious medical illness that would preclude study completion * no known immunodeficiency * no autoimmune disorders prior concurrent therapy: * no concurrent immunosuppression or systemic immunosuppressive medication * no concurrent dose escalation of imatinib mesylate * no other concurrent investigational products

Keywords: chronic myelogenous leukemia, bcr-abl1 positive accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia