Infusional C-myb ASODN in Advanced Hematologic Malignancies

Phase 1

Completed

• Conditions: Hematologic Malignancies
• Interventions: Drug: c-myb AS ODN

• Registration Number: NCT00780052
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-12
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	c-myb AS ODN	c-myb AS ODN as a 24-hour continuous infusion over 7 days

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN	At study completion

Trial Locations

Locations (1)

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States