Clinical trial NCT00058396: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Adam Weiss, MD
role: STUDY_CHAIR
References: