Clinical trial NCT00081068: Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
Official title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: Waldenström macroglobulinemia
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response
measure: Time to treatment failure
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Denver Midtown
state: Colorado
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Greenebaum Cancer Center at University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Hamilton
country: Canada
facility: McMaster Children's Hospital at Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Lens
country: France
facility: Centre Hospitalier Lens
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Jennifer Gansert, MD, PhD
role: STUDY_CHAIR
References: