Infusional C-myb ASODN in Advanced Hematologic Malignancies (UPCC 04701)
This study has been completed.
Sponsor:
University of Pennsylvania
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
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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 June 17, 2013