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Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia, Chronic Myeloide Leukemia, Myelodysplasia, Lymphoma, or Myeloma

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ClinicalTrials.gov Identifier: NCT00003885
Recruitment Status : Unknown
Verified June 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 18, 2004
Last Update Posted : November 6, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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 leukemia, chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Drug: arsenic trioxide Phase 2

Detailed Description:

OBJECTIVES: I. Determine the effect of arsenic trioxide on the remission rate in patients with recurrent or refractory acute leukemia, blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma. II. Determine the time to progression and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients are stratified into 1 of 8 categories: first relapse no greater than 6 months after complete response vs second relapse or refractory vs prior hematologic disorder vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs myeloma vs myelodysplasia. Patients receive IV arsenic trioxide over 2-3 hours for 5 consecutive days with 2 days of rest. Treatment continues in the absence of disease progression until complete response or 90 days is reached. Upon achieving complete response, treatment is discontinued for 30 days. Patients exhibiting complete response receive a second 28 day course of consolidation therapy while in remission starting no sooner than 31 days after the end of induction therapy. Patients are followed monthly.

PROJECTED ACCRUAL: A total of 14-29 patients per lymphoma and myeloma stratum and a total of 31 patients per leukemia stratum will be accrued for this study within 18-24 months.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Primary Purpose: Treatment
Official Title: Phase II Study of Arsenic Trioxide in Relapsed/Refractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia
Study Start Date : November 1997

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory acute leukemia (myeloid or lymphoid), blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma of all FAB subtypes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL (except for leukemic infiltration dysfunction) Alkaline phosphatase less than 2 times upper limit of normal (except for leukemic infiltration dysfunction) Renal: Creatinine no greater than 2.0 mg/dL Other: No active infection Not pregnant Fertile patients must use effective contraception No history of seizure disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior chemotherapy (except hydroxyurea) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents Concurrent antibiotic therapy allowed for stable patients

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003885


Locations
United States, New York
Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
Sponsors and Collaborators
Our Lady of Mercy Medical Center
Investigators
Study Chair: Janice P. Dutcher, MD Our Lady of Mercy Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00003885     History of Changes
Other Study ID Numbers: CDR0000067053
OLMMC-9808
OLMMC-FDR001699
NCI-V99-1545
First Posted: August 18, 2004    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: June 2000

Keywords provided by National Cancer Institute (NCI):
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
blastic phase chronic myelogenous leukemia
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
recurrent adult T-cell leukemia/lymphoma
previously treated myelodysplastic syndromes
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Arsenic trioxide
Antineoplastic Agents