Completed

Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers

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What is being tested

arsenic trioxide

Drug
Who is being recruted

Blood Protein Disorders+69

+ Bone Marrow Diseases

+ Cardiovascular Diseases

Over 17 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 1998
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1998

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Develop a safe, weight-based, extended-dosing regimen of arsenic trioxide suitable for outpatient therapy in patients with advanced hematologic cancers. II. Determine the pattern of clinical adverse experience in patients treated with this drug. III. Evaluate evidence of clinical responsiveness that may provide leads for further testing in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 1-4 hours on days 1-25. Courses repeat every 3-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed for 1 month. PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

NCT00003395
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersBone Marrow DiseasesCardiovascular DiseasesCell Transformation, NeoplasticChronic DiseaseDNA Virus InfectionsEye NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic ProcessesParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLymphoma, B-CellLymphoma, T-CellEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesMyelodysplastic-Myeloproliferative DiseasesCarcinogenesisBlast CrisisBurkitt LymphomaLeukemia, Erythroblastic, AcuteHodgkin DiseaseLeukemiaLeukemia, Hairy CellLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLymphomaLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaMultiple MyelomaMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Biphenotypic, AcuteLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLeukemia, Basophilic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Myelomonocytic, AcuteLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma CellLeukemia, Myelomonocytic, JuvenileIntraocular Lymphoma

Criteria

DISEASE CHARACTERISTICS: Histologically proven hematologic cancer, including acute or chronic leukemia, malignant lymphoma, or multiple myeloma Exclude acute promyelocytic leukemia (M3) Relapse from or resistance to at least one course of standard anticancer therapy and lack of alternative therapy that has proven to be curative in the underlying disease PATIENT CHARACTERISTICS: Age: 17 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 4 months after study No history of grand mal seizures (other than infantile febrile seizures) No active serious infections that are not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Memorial Sloan-Kettering Cancer Center

New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps
CompletedOne Study Center