Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies
Inclusion Criteria:
- Patients must have one of the following: acute myeloid or lymphoid leukemia; or
Myeloproliferative disorder(MPD) including Chronic Myelogenous Leukemia (CML); or
Myelodysplastic Syndrome (MDS); or Non-Hodgkin's Lymphoma (including CLL); or
Multiple Myeloma
- Patients with acute leukemia must meet one of the following conditions:
*have disease which is refractory to a course of standard induction chemotherapy
*have relapsed diseased after documentation of previous clinical remission or *have
untreated disease and not be a candidate for conventional first line treatment
- Patients with CML or other MPD must have evidence of accelerated phase or blast
crisis
- Patients having clinical features of CML in transformation but who are negative for
Philadelphia chromosome may be entered provided there is a prior definable chronic
phase
- Patients with Philadelphia chromosome positive CML must have failed treated with
Gleevec (Imatinib) in order to be eligible for study
- Patients with myelodysplastic syndrome (MDS) must have > 5% blasts in the peripheral
blood or bone marrow and have at diagnosis as IPSS score of >= 1
- Patients with CLL must have relapsed or refractory disease after at least three
courses of conventional therapy and have been determined to no longer be a candidate
for conventional therapy
- Patients with non-Hodgkin's lymphoma (other than CLL) must have relapsed or
refractory disease after at least two courses of chemotherapy and have been
determined not to be a candidate for further conventional therapies
- Patients with multiple myeloma must have failed at least 3 prior therapies
- Performance Status 0, 1 or 2
- Serum creatinine < 2.0 mg/dl; serum bilirubin < 2 mg/dl and AST/ALT < 3.0 x upper
limit of normal
- PTT within normal range
- Age > 18
- Patients must have an indwelling central venous catheter
Exclusion Criteria:
- Significant cardiac disease which requires active therapy
- Intercurrent organ damage or medical problems that will jeopardize outcome of therapy
- Pregnant or lactating females
- Received prior c-myb AS ODN therapy
- Patients with suitable HLA identical sibling donor who are deemed to be appropriate
and willing candidates for allogeneic bone marrow transplantation
- Patients requiring anticoagulation with unfractionated heparin.