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Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mark Adam Weiss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

IDEC-152-20

NCT ID:

NCT00058396

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021