Monoclonal Antibody Therapy in Treating Patients With Myelodysplastic Syndrome or Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

June 24, 2013 updated by: Memorial Sloan Kettering Cancer Center

PHASE I DOSE-ESCALATION TRIAL OF YTTRIUM-90-LABELED HuM195 (HUMANIZED ANTI-CD33) IN PATIENTS WITH ADVANCED MYELOID MALIGNANCIES

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 radiolabeled monoclonal antibody in treating patients with myelodysplastic syndrome or relapsed or refractory acute myeloid leukemia or chronic myelogenous leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the safety and toxicity of yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195) in patients with relapsed or refractory myeloid malignancies. II. Determine the pharmacology and dosimetry of 90Y-MOAB HuM195. III. Study the biological effects of 90Y-MOAB HuM195, including the ability to elicit human anti-human antibody responses and antileukemic responses.

OUTLINE: This study seeks to estimate the maximum tolerated dose (MTD) of yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195). All patients receive a single intravenous dose of 90Y-MOAB HuM195. Groups of 3 to 6 patients are treated at escalated doses of yttrium-90 until the MTD is determined. Patients with active leukemia who exhibit at least a 50% clearing of marrow blasts after the first dose may receive a second dose after 4-8 weeks provided remaining blasts are CD33-positive, there is no evidence of human anti-human antibody response, and any toxicity has resolved. All patients are followed monthly for 4 months after treatment.

PROJECTED ACCRUAL: Up to 24 patients will be treated. The study is expected to require 12-18 months to complete.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Pathologically confirmed myeloid malignancies as follows: Acute myelogenous leukemia that is relapsed or refractory after at least 2 courses of standard induction chemotherapy Accelerated or myeloblastic chronic myelogenous leukemia Refractory anemia with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia More than 25% of bone marrow blasts positive for the CD33 antigen Clear signs of active leukemia following recovery from prior therapy required No rapidly accelerating blast count No clinically unstable disease No active CNS leukemia

PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Karnofsky 60%-100% Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No NYHA class III/IV status Pulmonary: No clinically significant pulmonary disease Other: No serious infection uncontrolled by antibiotics No pregnant or nursing women Negative pregnancy test required of fertile women

PRIOR CONCURRENT THERAPY: Recovered from prior therapy Biologic therapy: No detectable antibodies to M195 from prior monoclonal antibody M195 or HuM195 Chemotherapy: At least 2 days since hydroxyurea At least 3 weeks since other chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since radiotherapy Surgery: Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1996

Primary Completion (ACTUAL)

January 1, 2001

Study Completion (ACTUAL)

January 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 10, 2004

First Posted (ESTIMATE)

August 11, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-010
  • CDR0000065213 (REGISTRY: PDQ (Physician Data Query))
  • NCI-H96-1100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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