Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-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 chronic lymphocytic leukemia.


Study summary:

OBJECTIVES: - Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) in patients with T-cell large granular lymphocytic leukemia associated with granulocytopenia, anemia, or thrombocytopenia. - Determine the clinical response in patients treated with this drug. - Assess the effect of this drug on the number of circulating CD3+, CD8+ expressing granular lymphocytes and the number of polymorphonuclear leukocytes, red blood cells, and platelets in this patient population. - Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1 and for the production of human antibodies to IV infused murine MOAB Mik-beta-1. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) IV over 2 hours on days 1, 4, 7, and 10. Patients achieving a complete response (CR) or partial response (PR) may receive 1 additional course beginning no sooner than 4 weeks after completion of the first course, in the absence of antibodies to MOAB Mik-beta-1. Treatment continues in the absence of disease progression, unacceptable toxicity, or severe allergic reaction. Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 6-10 days and at 4-6 weeks after therapy. Patients with a PR or CR may be followed every 6 months for 2 years or until relapse. All patients are followed for survival. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia associated with clinically significant hematocytopenia demonstrated by one of the following values while off growth factor support: - Absolute neutrophil count less than 1,000/mm^3 - Hemoglobin less than 8 g/dL - Platelet count less than 50,000/mm^3 - Clinically evaluable disease with peripheral blood T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS - Monoclonal T-cell population in peripheral blood (circulating mononuclear cells) demonstrated by TCR beta or gamma chain gene rearrangement PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 50-100% Life expectancy: - More than 2 months Hematopoietic: - See Disease Characteristics - No active major bleeding episode within the past 4 weeks Hepatic: - Direct bilirubin less than 1.5 mg/dL Renal: - Creatinine less than 2.0 mg/dL Other: - No concurrent serious active infection - Patients with fever without apparent site of infection may begin study while on antibiotics as long as the following are true: - No pathogenic organism in culture - Afebrile (maximum temperature less than 38°C) for at least 5 days - HIV negative - No other primary cancer other than basal cell skin cancer - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior interferon - Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11, or similar sustained-release/long-acting product (e.g., pegylated G-CSF) allowed if dose established at least 4 weeks prior to study participation - No concurrent interferon Chemotherapy: - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - Concurrent corticosteroids allowed if dose established at least 3 weeks prior to study participation Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 1 week since completion of prior antibiotic regimen for serious infectious episode - No other concurrent investigational drugs


Study is Available At:


Original ID:

CDR0000064038


NCT ID:

NCT00019032


Secondary ID:

NCI-95-C-0054K


Study Acronym:


Brief Title:

Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia


Official Title:

PHASE I STUDY OF T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Thomas A. Waldmann, MD
Study Chair
NCI - Metabolism Branch;MET

Study Dates

Start Date:March 1996
Verification Date:April 2004
Last Changed Date:April 27, 2015
First Received Date:July 11, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:monoclonal antibody Mik-beta-1

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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