Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: lumiliximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia |
| Study Start Date: | October 2002 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Mark Adam Weiss, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00058396 History of Changes |
| Other Study ID Numbers: | CDR0000288828, MSKCC-02096, IDEC-152-20 |
| Study First Received: | April 7, 2003 |
| Last Updated: | December 13, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013