Infusional C-myb ASODN in Advanced Hematologic Malignancies

Hematologic Malignancies Clinical Trial

— UPCC 04701  

Official title:

Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780052
• Other study ID #: UPCC 04701
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2008
• Last updated: September 23, 2016
• Start date: September 2002
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN		At study completion	Yes