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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014