Infusional C-myb ASODN in Advanced Hematologic Malignancies (UPCC 04701)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00780052
First received: October 24, 2008
Last updated: December 19, 2011
Last verified: December 2011

October 24, 2008
December 19, 2011
September 2002
August 2011   (final data collection date for primary outcome measure)
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN [ Time Frame: At study completion ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00780052 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Infusional C-myb ASODN in Advanced Hematologic Malignancies
Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematologic Malignancies
Drug: c-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.
Experimental: 1
c-myb AS ODN as a 24-hour continuous infusion over 7 days
Intervention: Drug: c-myb AS ODN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00780052
UPCC 04701
Yes
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Selina Luger, MD University of Pennsylvania Abramson Cancer Center
University of Pennsylvania
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP