NCT00005618

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory chronic myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2000

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
Last Updated

June 21, 2013

Status Verified

October 1, 2001

First QC Date

May 2, 2000

Last Update Submit

June 20, 2013

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemia

Interventions

arsenic trioxideDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Chronic myelogenous leukemia (CML) confirmed by: Cytogenetic testing demonstrating presence of t(9:22) OR RT-PCR demonstrating presence of BCR/ABL rearrangement Chronic phase Blast count less than 15% OR Accelerated phase defined by 1 or more of the following: Blast count greater than 15% but less than 30% Blast count and promyelocytes greater than 30% Basophils greater than 20% Thrombocytopenia less than 100,000/mm3 not related to therapy Cytogenetic clonal evolution (13) OR Blastic phase Blast count greater than 30% OR Evidence of extramedullary blasts Relapse from or failure to achieve a major cytogenetic response to at least 1 course of standard anti-CML therapy including interferon alfa or cytotoxic chemotherapy Must have failed adequate trial of interferon alfa unless intolerance to or contraindication to interferon alfa Not eligible for allogeneic stem cell transplant PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after study No active serious infections that are not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior interferon alfa Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (1 day for hydroxyurea) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents

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

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast Crisis

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • David A. Scheinberg, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

April 2, 2004

Study Start

February 1, 2000

Study Completion

March 1, 2004

Last Updated

June 21, 2013

Record last verified: 2001-10

Locations

US(1)