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
  Purpose

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


Condition Intervention Phase
Hematologic Malignancies
Drug: c-myb AS ODN
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: September 2002
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
c-myb AS ODN as a 24-hour continuous infusion over 7 days
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780052

Locations
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Selina Luger, MD University of Pennsylvania Abramson Cancer Center
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00780052     History of Changes
Other Study ID Numbers: UPCC 04701
Study First Received: October 24, 2008
Last Updated: December 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Hematologic Malignancies
c-myb
c-myb AS ODN

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on April 14, 2014