Infusional C-myb ASODN in Advanced Hematologic Malignancies (UPCC 04701)
Primary Purpose
Hematologic Malignancies
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
c-myb AS ODN
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Malignancies focused on measuring Hematologic Malignancies, c-myb, c-myb AS ODN
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.
Sites / Locations
- University of Pennsylvania Abramson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
c-myb AS ODN as a 24-hour continuous infusion over 7 days
Outcomes
Primary Outcome Measures
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
Secondary Outcome Measures
Full Information
NCT ID
NCT00780052
First Posted
October 24, 2008
Last Updated
September 23, 2016
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00780052
Brief Title
Infusional C-myb ASODN in Advanced Hematologic Malignancies
Acronym
UPCC 04701
Official Title
Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Hematologic Malignancies, c-myb, c-myb AS ODN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
c-myb AS ODN as a 24-hour continuous infusion over 7 days
Intervention Type
Drug
Intervention Name(s)
c-myb AS ODN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
Time Frame
At study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selina Luger, MD
Organizational Affiliation
University of Pennsylvania Abramson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Infusional C-myb ASODN in Advanced Hematologic Malignancies
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