NCT00006092

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 recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Aug 2000

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2000

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

2.6 years

First QC Date

August 3, 2000

Last Update Submit

September 25, 2012

Conditions

Leukemia

Keywords

recurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic myelogenous leukemia, BCR-ABL1 positivelymphoid leukemiamyeloid and monocytic leukemia

Outcome Measures

Primary Outcomes (1)

  • Objective Rate of Response (ORR)

    Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.

    2.5 years

Study Arms (1)

Arsenic Trioxide Treatment

EXPERIMENTAL

Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.

Drug: Arsenic Trioxide

Interventions

Arsenic TrioxideDRUG
Also known as: Trisenox
Arsenic Trioxide Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Acute lymphoblastic leukemia * Philadelphia chromosome (Bcr-abl) positive * Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation * Blastic phase chronic myelogenous leukemia * Philadelphia chromosome (Bcr-abl) positive * Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate * Must not be eligible for bone marrow transplant PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 times upper limit of normal (ULN) * AST/ALT no greater than 2 times ULN Renal: * Creatinine no greater than 2.0 times ULN * Creatinine clearance greater than 70 mL/min Cardiovascular: * No uncontrolled angina * No New York Heart Association class III or IV heart disease * No second degree heart block without pacemaker Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * HIV negative * No uncontrolled infection or other serious concurrent illness * No peripheral neuropathy * No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR * No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected * Electrolyte imbalances must be corrected prior to study entry PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * At least 28 days since prior chemotherapy * At least 24 hours since prior hydroxyurea * No prior arsenic trioxide * No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia Endocrine therapy: * Not specified Radiotherapy: * At least 28 days since prior radiotherapy * No concurrent radiotherapy including for palliation Surgery: * Not specified Other: * At least 14 days since prior imatinib mesylate * No other concurrent investigational agents * No concurrent amphotericin B

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

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaBlast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, LymphoidLeukemia, Monocytic, Acute

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myeloid, Acute

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Thomas P. Loughran, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

US(1)