Infusional C-myb ASODN in Advanced Hematologic Malignancies

NCT ID: NCT00780052

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2011-08-31

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.

Conditions

Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

c-myb AS ODN as a 24-hour continuous infusion over 7 days

Group Type: EXPERIMENTAL

c-myb AS ODN

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Selina Luger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Abramson Cancer Center

Locations

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 04701

Identifier Type: -

Identifier Source: org_study_id