Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer.

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Key information

Conditions

Leukemia Blast Crisis Blood Protein Disorders Bone Marrow Diseases Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Eye Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Intraocular Lymphoma Leukemia, B-Cell Leukemia, Basophilic, Acute Leukemia, Biphenotypic, Acute Leukemia, Eosinophilic, Acute Leukemia, Erythroblastic, Acute Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Megakaryoblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Juvenile Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Sezary Syndrome Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arsenic trioxide

Drug

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers

Important dates

Study start: 1998
Primary completion: 2000
Study completion: 2000
First posted: Aug 16, 2004
Registry last updated: Jun 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed