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Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers


Phase 1
17 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven Soignet, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-023

NCT ID:

NCT00003395

Start Date:

April 1998

Completion Date:

March 2000

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • refractory multiple myeloma
  • Waldenström macroglobulinemia
  • stage III multiple myeloma
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute eosinophilic leukemia
  • adult acute basophilic leukemia
  • adult acute megakaryoblastic leukemia (M7)
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • acute undifferentiated leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • adult acute monocytic leukemia (M5b)
  • primary central nervous system non-Hodgkin lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • adult acute minimally differentiated myeloid leukemia (M0)
  • intraocular lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • anaplastic large cell lymphoma
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • juvenile myelomonocytic leukemia
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Lymphoma, Large-Cell, Immunoblastic
  • Hematologic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021