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Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia

NCT ID: NCT00006084

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Brief Summary

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RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating patients who have acute myelogenous leukemia that did not respond to standard treatment given in clinical trial PDL 195-301.

Detailed Description

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OBJECTIVES: I. Determine the safety and efficacy of monoclonal antibody HuG1-M195 as demonstrated by frequency of complete remission (CR) in patients with acute myelogenous leukemia with regimen failure on the control arm of PDL Study 195-301. II. Determine additional evidence of clinical benefit of this treatment as demonstrated by frequency of partial remission (PR), durations of CR and PR, and progression free and overall survival in these patients.

OUTLINE: This is a multicenter study. Patients receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 1-4 every 2 weeks for 4 courses. Patients without disease progression after completion of course 4 continue to receive MOAB HuM195 as above. Treatment repeats every month for a maximum of 8 additional courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study.

Conditions

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Leukemia

Keywords

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recurrent adult acute myeloid leukemia adult acute erythroid leukemia (M6) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute megakaryoblastic leukemia (M7) secondary acute myeloid leukemia adult acute monocytic leukemia (M5b) adult acute minimally differentiated myeloid leukemia (M0)

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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lintuzumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia (AML) with documented regimen failure on the control arm (standard chemotherapy alone) of PDL study 195-301 Regimen failure, defined as: Bone marrow blasts greater than 10% and rising (according to 2 sequential bone marrow samples obtained 1-2 weeks apart) OR Bone marrow blasts greater than 20% Must enroll within 2 weeks after documented regimen failure No active CNS leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration) SGOT and SGPT no greater than 4 times upper limit of normal (unless related to AML) Renal: Creatinine less than 2.0 mg/dL (unless related to AML) Cardiovascular: Left ventricular function normal No significant cardiovascular disease (e.g., unstable cardiac arrhythmias or unstable angina pectoris) No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No active ischemia by EKG Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No active serious infection not controlled by antimicrobial therapy No other active malignancy requiring therapy Medically stable No significant organ dysfunction

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy, including bone marrow transplantation, for AML after termination from PDL Study 195-301 No other concurrent biologic therapy for AML Chemotherapy: See Disease Characteristics No additional chemotherapy for AML after termination from PDL Study 195-301 No concurrent chemotherapy for AML Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for AML after termination from PDL Study 195-301 No concurrent radiotherapy for AML Surgery: Not specified Other: No other concurrent experimental therapy for AML
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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Christos E. Emmanouilides, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Locations

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Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA016042

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCLA-9910096

Identifier Type: -

Identifier Source: secondary_id

PDL-195-302

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1823

Identifier Type: -

Identifier Source: secondary_id

CDR0000068076

Identifier Type: -

Identifier Source: org_study_id