Infusional C-myb ASODN in Advanced Hematologic Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.

Official Title
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Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies

Conditions
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Hematologic Malignancies

Intervention / Treatment
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* Drug: c-myb AS ODN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>c-myb AS ODN as a 24-hour continuous infusion over 7 days | Drug: c-myb AS ODN<br>* Subjects will be admitted to the hospital to receive c-myb AS ODN as a 24-hour continuous intravenous infusion over 7 days. Dose level is increased with each new subject to determine if there is a MTD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN |  | At study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematologic Malignancies, c-myb, c-myb AS ODN