Clinical trial NCT00780052: Infusional C-myb ASODN in Advanced Hematologic Malignancies
Official title: Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Malignancies
Keywords: Hematologic Malignancies
c-myb
c-myb AS ODN
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
timeFrame: At study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Abramson Cancer Center
name: Selina Luger, MD
role: PRINCIPAL_INVESTIGATOR
References: