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Phase II Study of Arsenic Trioxide in Relapsed/Refractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

Phase II Study of Arsenic Trioxide in Relapsed/Refractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Janice P. Dutcher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Our Lady of Mercy Medical Center Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067053

NCT ID:

NCT00003885

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • 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
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Our Lady of Mercy Medical Center Bronx, New York  10466