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

2014-07-24 14:33:43 | BioPortfolio

Summary

RATIONALE: Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.

PURPOSE: 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.

Description

OBJECTIVES:

- Determine the maximum tolerated dose and recommended phase II dose of oblimersen in patients with relapsed or refractory Waldenstrom's macroglobulinemia.

- Determine the response rate and duration of response in patients treated with this drug.

- Determine the safety of this drug in these patients.

- Determine the survival of patients treated with this drug.

- Determine the use of epoetin alfa in patients treated with this drug.

- Determine the clinical benefit of this drug, in terms of improvement in hemoglobin (greater than 11 g/dL) and platelet count (greater than 100,000/mm^3), in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

- Phase I: Patients receive oblimersen IV continuously on days 1-7. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive treatment as in phase I at the MTD of oblimersen. Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A maximum of 61 patients will be accrued for this study within approximately 3.2 years.

Study Design

Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

oblimersen sodium

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:33:43-0400

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Medical and Biotech [MESH] Definitions

A leukemia/lymphoma found predominately in children and young adults and characterized LYMPHADENOPATHY and THYMUS GLAND involvement. It most frequently presents as a lymphoma, but a leukemic progression in the bone marrow is common.

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.

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Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

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