Infusional C-myb ASODN in Advanced Hematologic Malignancies (UPCC 04701)

Abramson Cancer Center at Penn Medicine

Status and phase

Completed

Phase 1

Conditions

Hematologic Malignancies

Treatments

Drug: c-myb AS ODN

Study type

Interventional

Funder types

Other

Identifiers

NCT00780052

UPCC 04701

Details and patient eligibility

About

The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.