Infusional C-myb ASODN in Advanced Hematologic Malignancies

Completed · Phase 1

Conditions studied: Hematologic Malignancies

In brief

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

Key facts

Study ID

NCT00780052

Run by

Abramson Cancer Center at Penn Medicine

People needed

13

Starts

2002-09-01

Expected to finish

2011-08-01

Last updated by the study team

2016-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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