Infusional C-myb ASODN in Advanced Hematologic Malignancies

NCT00780052 | Completed Phase 1 DMC

• 1 other identifier: UPCC 04701
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Hematologic Malignancies; c-myb; c-myb AS ODN

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN

  At study completion

Study Arms (1)

1

EXPERIMENTAL

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

Drug: c-myb AS ODN

Interventions

c-myb AS ODN 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Genes, myb

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Selina Luger, MD

  University of Pennsylvania Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 27, 2008
• Study Start: September 1, 2002
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 26, 2016

Record last verified: 2011-12

Locations

US (1)