Infusional C-myb ASODN in Advanced Hematologic Malignancies

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania

Criteria

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.