Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

Official title:

Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00081068
• Other study ID #: CDR0000358811
• Secondary ID: UCLA-0309058
• Status: Withdrawn
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: January 7, 2013
• Start date: January 2004

Study information

• Verified date: January 2013
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

Description:

OBJECTIVES:

• Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab.

• Determine the time to treatment failure in patients treated with this drug.

• Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)

• Immunoglobulin (Ig) M, IgG, and IgA paraprotein

• Measurable monoclonal paraprotein

• Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)

• CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Absolute neutrophil count = 500/mm^3

• Platelet count = 25,000/mm^3

Hepatic

• SGOT = 2.5 times upper limit of normal (ULN)

• Bilirubin = 2.5 times ULN

Renal

• Creatinine = 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method contraception during and for 6 months after study participation

• No serious comorbid disease

• No uncontrolled bacterial, fungal, or viral infection

• No other active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• No prior alemtuzumab

• More than 3 months since other prior monoclonal antibody therapy

Chemotherapy

• See Disease Characteristics

• More than 21 days since prior chemotherapy

Endocrine therapy

• More than 21 days since prior steroid therapy

Radiotherapy

• More than 21 days since prior radiotherapy

Surgery

• Not specified

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Biological:
• alemtuzumab

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Canada	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
France	Centre Hospitalier Lens	Lens
United Kingdom	Saint Bartholomew's Hospital	London	England
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Rocky Mountain Cancer Centers - Denver Midtown	Denver	Colorado
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response			No
Primary	Time to treatment failure			No
Primary	Toxicity			Yes