Status:
COMPLETED
Infusional C-myb ASODN in Advanced Hematologic Malignancies
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00780052
Start Date
September 1 2002
End Date
August 1 2011
Last Update
September 26 2016
Active Locations (1)
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1
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104