NCT00002890

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Oct 1996

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

4.3 years

First QC Date

November 1, 1999

Last Update Submit

June 24, 2013

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

recurrent adult acute myeloid leukemiarelapsing chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromeschildhood myelodysplastic syndromes

Interventions

lintuzumabBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Myeloid, Accelerated PhaseBlast CrisisAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, Chronic

Interventions

lintuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesAnemia, RefractoryAnemiaMyelodysplastic-Myeloproliferative Diseases

Study Officials

  • Joseph G. Jurcic, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2004

Study Start

October 1, 1996

Primary Completion

January 1, 2001

Study Completion

January 1, 2001

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)