Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia

Completed · Phase 1/Phase 2

Conditions studied: Waldenström Macroglobulinemia

In brief

This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.

Key facts

Study ID

NCT00062244

Run by

National Cancer Institute (NCI)

People needed

58

Starts

2003-05-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Waldenstrom's macroglobulinemia (WM) confirmed by both of the following:
• Bone marrow lymphoplasmacytosis with greater than 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy
• Measurable disease, defined by quantitative IgM monoclonal protein greater than 1,000 mg/dL
• Symptomatic relapsed or refractory disease requiring therapy, defined by at least 1 of the following:
• Impaired bone marrow function due to disease infiltration as demonstrated by any of the following:
• Hemoglobin less than 11 g/dL
• Requires epoetin alfa therapy to maintain hemoglobin of at least 11 g/dL
• Platelet count less than 100,000/mm\^3
• Symptomatic bulky lymphadenopathy
• Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, or retinal hemorrhage) or serum viscosity level relative to water greater than 4
• Received at least 1 prior chemotherapy regimen which included chlorambucil, cyclophosphamide, fludarabine, cladribine, or pentostatin
• No secondary leukemia or history of antecedent hematologic disorder (e.g., myelodysplasia) prior to initial onset of WM
• Performance status - ECOG 0-2
• Not specified
• See Disease Characteristics
• Absolute neutrophil count at least 1,000/mm\^3*
• Platelet count at least 50,000/mm\^3*
• No bleeding disorder
• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST less than 1.5 times ULN
• Albumin at least 2.5 g/dL
• PT no greater than 1.5 times ULN
• INR no greater than 1.3
• PTT no greater than 1.5 times ULN
• No history of chronic hepatitis or cirrhosis

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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