Hematologic Malignancies
Conditions
Keywords
Hematologic Malignancies, c-myb, c-myb AS ODN
Brief summary
The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.
Interventions
DRUGc-myb AS ODN
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.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN | At study completion |
Countries
United States
Outcome results
None listed