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Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lumiliximab
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, noncontiguous stage II small lymphocytic lymphoma, recurrent small lymphocytic lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma Stage III-IV OR Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics: Rapid doubling of peripheral lymphocyte count Progressive lymphadenopathy Progressive splenomegaly B symptoms Grade 2 or 3 fatigue CD23+ disease Progressive disease after at least 1 prior chemotherapy course PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy At least 6 months Hematopoietic Platelet count at least 50,000/mm^3 Hepatic Bilirubin no greater than 2.0 mg/dL AST/ALT no greater than 1.5 times upper limit of normal (ULN) Renal Creatinine no greater than 1.5 times ULN Cardiovascular No New York Heart Association class III or IV cardiac disease No myocardial infarction within the past 6 months No unstable arrhythmia No evidence of ischemia on EKG within the past 14 days Pulmonary FEV_1 at least 60% of predicted DLCO at least 55% of predicted Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study treatment HIV negative No secondary malignancy requiring active treatment (except hormonal therapy) No serious nonmalignant disease that would preclude study participation No active uncontrolled bacterial, viral, or fungal infection No clinically active autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior anticancer biologic therapy More than 4 weeks since prior anticancer radioimmunotherapy No prior exposure to IDEC-152 or anti-CD23 antibodies Chemotherapy See Disease Characteristics More than 4 weeks since prior anticancer chemotherapy Endocrine therapy Concurrent hormonal therapy allowed for second malignancy Radiotherapy More than 4 weeks since prior anticancer radiotherapy Surgery More than 4 weeks since prior major surgery (except for diagnostic surgery) Other More than 4 weeks since prior anticancer investigational therapy No other concurrent anticancer therapy

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
May 29, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058396
Brief Title
Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official Title
Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Detailed Description
OBJECTIVES: Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia. Determine the safety profile of this drug in these patients. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. Determine the efficacy of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1, 2, 8, 15, and 22. Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, noncontiguous stage II small lymphocytic lymphoma, recurrent small lymphocytic lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
lumiliximab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma Stage III-IV OR Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics: Rapid doubling of peripheral lymphocyte count Progressive lymphadenopathy Progressive splenomegaly B symptoms Grade 2 or 3 fatigue CD23+ disease Progressive disease after at least 1 prior chemotherapy course PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy At least 6 months Hematopoietic Platelet count at least 50,000/mm^3 Hepatic Bilirubin no greater than 2.0 mg/dL AST/ALT no greater than 1.5 times upper limit of normal (ULN) Renal Creatinine no greater than 1.5 times ULN Cardiovascular No New York Heart Association class III or IV cardiac disease No myocardial infarction within the past 6 months No unstable arrhythmia No evidence of ischemia on EKG within the past 14 days Pulmonary FEV_1 at least 60% of predicted DLCO at least 55% of predicted Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study treatment HIV negative No secondary malignancy requiring active treatment (except hormonal therapy) No serious nonmalignant disease that would preclude study participation No active uncontrolled bacterial, viral, or fungal infection No clinically active autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior anticancer biologic therapy More than 4 weeks since prior anticancer radioimmunotherapy No prior exposure to IDEC-152 or anti-CD23 antibodies Chemotherapy See Disease Characteristics More than 4 weeks since prior anticancer chemotherapy Endocrine therapy Concurrent hormonal therapy allowed for second malignancy Radiotherapy More than 4 weeks since prior anticancer radiotherapy Surgery More than 4 weeks since prior major surgery (except for diagnostic surgery) Other More than 4 weeks since prior anticancer investigational therapy No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Adam Weiss, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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